Top 10 most anticipated drug launches of 2025
In the latest edition of its annual ranking of the biggest potential drug launches of the coming year, Evaluate listed 10 drugs that are slated to earn approvals in 2025. According to the analysts’ forecasts, all together, the meds stand to generate a whopping $29 billion in annual sales by the end of the decade.
That’s nearly double the estimate for last year’s top 10. In that case, Evaluate calculated a conservative $15.2 billion in 2028 sales for 2024’s biggest expected launches, which included the likes of Bristol Myers Squibb’s schizophrenia drug Cobenfy, Eli Lilly’s Alzheimer’s disease med Kisunla and Madrigal Pharmaceuticals’ MASH treatment Rezdiffra in the top three—all of which were indeed approved throughout last year.
In fact, 2025’s total is the highest in the last five years, topping even Evaluate’s high-flying forecast for 2022, when the analysts estimated total 2026 sales of $26.9 billion for the year’s most anticipated drug launches. That list included an early bet on Kisunla as well as Lilly’s tirzepatide—now sold as Zepbound and Mounjaro—and the Alzheimer’s candidate gantenerumab, which Roche’s Genentech ended up discontinuing before the end of that year following a phase 3 trial fail.
So, what exactly is responsible for the predicted 2030 deluge? Topping Evaluate’s 2025 list is a new cystic fibrosis offering from Vertex Pharmaceuticals, already a giant in the space. Vanza triple snagged its FDA approval a bit early, at the end of 2024, after which it was christened with the commercial name Alyftrek. The triple combination drug improves on its predecessor Trikafta in multiple areas, and Evaluate is predicting a massive $8.3 billion annual haul for Alyftrek by 2030.
Second on this year’s slate is a repeat from last year. Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan, which came in at No. 5 in 2024, didn’t end up earning an FDA nod last year. It's already off to a strong start in 2025, though, as the antibody-drug conjugate gained its first approval in January. Evaluate is predicting 2030 sales of nearly $6 billion for the drug, which is now marketed as Datroway.
Rounding out the top three is another Vertex asset: suzetrigine, which could set a new standard in non-opioid pain management. An FDA decision date has been set for the end of this month; if it brings an approval, the NaV1.8 inhibitor will become “the first novel pain mechanism to reach the market for decades,” per Evaluate. With that groundbreaking potential in mind, the analysts are forecasting annual sales of just under $3 billion for suzetrigine by 2030.Elsewhere on this year’s list are offerings from Sanofi, GSK, Johnson & Johnson and more, spanning indications such as multiple sclerosis, severe asthma and, of course, the hyperpopular obesity and Type 2 diabetes space.
1. Vanza triple
Company: Vertex PharmaceuticalsUsed for: Cystic fibrosis
Est. 2030 sales: $8.3 billion
The first entry on Evaluate’s list of the most anticipated drug launches of this year is also the first to get the go-ahead to begin that launch. Vertex won FDA approval for its newest cystic fibrosis treatment, Alyftrek, in late December 2024, about two weeks ahead of a planned PDUFA date.
The drug, a triple combination of vanzacaftor, tezacaftor and deutivacaftor that was previously known as vanza triple, is Vertex’s fifth cystic fibrosis transmembrane conductance regulator (CFTR) modulator to gain the regulator’s approval. It's the first in the group designed to be administered just once daily.
The FDA cleared the drug for use by CF patients ages 6 and older who have genetic mutations responsive to the therapy.
As CEO Reshma Kewalramani, M.D., noted in the company's approval announcement, Alyftrek expands the reach of Vertex’s CF franchise into 31 additional mutations. Vertex estimates this will allow about 150 CF patients in the U.S. to become eligible for a CFTR modulator treatment for the first time.
Alyftrek also improves on the sweat chloride levels associated with the use of Vertex’s Trikafta, which in 2019 became the first triple combination therapy for CF to earn the FDA’s green light with a label spanning approximately 90% of the CF patient population.
The Alyftrek approval was based on the results of what Vertex has termed “the most comprehensive Phase 3 pivotal program ever conducted in CF,” as it included more than 1,000 patients in around two dozen countries.
The studies showed that, in patients aged 12 and up, Alyftrek was noninferior to Trikafta in terms of ppFEV1, a measure of how much air an individual can forcefully exhale in one second, and it also outdid its predecessor in the reduction of sweat chloride. Meanwhile, a study in children ages 6 to 11 proved Alyftrek’s safety in the younger population.
Like Trikafta before it, Alyftrek comes with a black box warning about the risk of liver toxicities, mandating annual liver function monitoring and frequent tests during the first year of treatment.
In a presentation at the annual J.P. Morgan Healthcare Conference earlier this month, Stuart Arbuckle, Vertex’s chief operating officer, outlined three main patient groups for whom Alyftrek will be “particularly interesting." Those are patients with the 31 mutations not treated by Trikafta, those currently taking Trikafta who “would like the benefits of greater CFTR function and also the convenience of once-daily dosing,” and the approximately 6,000 patients around the world who have discontinued the use of a CFTR modulator, according to Arbuckle.
Analysts have suggested that while the conversion of patients to Alyftrek will be “fairly straightforward,” the drug will likely make a smaller initial splash than Trikafta did in 2019 when it arrived on the scene as the first-ever triple combination therapy for CF, with efficacy results far outperforming those of Vertex’s previous offerings.
Even so, Evaluate has pegged Alyftrek’s 2030 sales at more than $8 billion, well above the other entries on this list, based at least in part on “the success of the company’s existing CF franchise”—already a $10 billion juggernaut—which the firm said bodes well for “another commercial hit.”
A company securities filing at the time of the approval noted a planned annual list price of $370,269 for Alyftrek, 7% higher than Trikafta’s $346,048.
With Alyftrek’s approval secured in the U.S., Vertex now awaits additional international nods; the company has already submitted applications in the EU, the U.K., Canada, Switzerland, Australia and New Zealand.
The FDA recently accepted the lung cancer filing for priority review. AstraZeneca
2. Datopotamab deruxtecan
Company: Daiichi Sankyo/AstraZenecaUsed for: Lung and breast cancers
Est. 2030 sales: $5.9 billion
Daiichi Sankyo and AstraZeneca’s TROP2-directed datopotamab deruxtecan (Dato-DXd) could be the next big antibody-drug conjugate (ADC) from the teams behind Enhertu. However, doubts raised by patient deaths in 2023 intensified in 2024 as the partners suffered a series of setbacks.
Last year, Dato-DXd failed to improve overall survival (OS) in phase 3 lung and breast cancer trials. When its makers shared a closer look at the lung cancer data, Daiichi’s stock dropped as investors unpacked the implications of an OS fail that was worse than expected. The partners withdrew filings for approval for use in second-line lung cancer patients in the U.S. and Europe as 2024 drew to a close.
Speaking at an event in December, Dale Shuster, head of global precision medicine at Daiichi, said the lung cancer trial “was not reviewed favorably with the FDA.” The partners are now seeking FDA approval in a subset of second-line non-small cell lung cancer (NSCLC) patients with EGFR-mutated tumors.
Shuster was speaking shortly after AstraZeneca and Daiichi shared the analyses behind the pivot to the NSCLC subgroup. A pooled analysis of EGFR-mutated patients from two trials found median OS in people on Dato-DXd was 15.6 months. Median OS in the overall population of the phase 3 trial was 12.9 months on Dato-DXd and 11.8 months on docetaxel, the chemotherapy drug used in the control cohort.
The FDA recently accepted the lung cancer filing for priority review, positioning it to make a decision on the submission by July 12. Meanwhile, AstraZeneca and Daiichi won the first FDA approval for Dato-DXd on Jan. 17, securing a green light to sell the ADC in unresectable or metastatic HR-positive, HER2-negative breast cancer.
Gilead Sciences’ rival TROP2 ADC Trodelvy is already approved in breast cancer, but Dato-DXd, which will be sold as Datroway, is authorized for earlier use. While patients need to have tried endocrine-based therapy and at least two additional systemic therapies to start on Trodelvy, the Datroway label allows use after endocrine-based therapy and at least one additional systemic therapy.
Lung cancer is the bigger opportunity, though, and Gilead exited the second-line race after failing a phase 3 trial last year. While working to win approval in the subset of second-line NSCLC patients, AstraZeneca and Daiichi are also advancing toward data from a phase 3 trial that is testing their ADC as a first-line treatment for lung cancer. Data from the first-line AVANZAR trial are due in the second half of the year.
Positive AVANZAR data would open up a major market. Working with Merck & Co., Gilead is still trying to bring Trodelvy to the first-line NSCLC market, so AstraZeneca and Daiichi have a chance to leap ahead and launch the first TROP2-directed ADC in the indication.
Evaluate’s forecast suggests the analysts continue to believe in Dato-DXd despite the setbacks it faced in recent years, with their estimate for 2030 coming in $4.1 billion above the 2028 prediction they made one year ago. The coming 12 months will go a long way toward showing whether Dato-DXd can become the big blockbuster expected by analysts.
Vertex executives discussed the company's launch preparations at the recent J.P. Morgan Healthcare Conference. Photo by David L. Ryan/The Boston Globe via Getty Images
3. Suzetrigine
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| Cytokinetics is set to post phase 3 data from a trial that is comparing aficamten to a beta blocker in the first half of 2025. iStock / Getty Images Plus |
Company: Vertex Pharmaceuticals
Used for: Acute and neuropathic pain
Est. 2030 sales: $2.9 billion
Though the 2030 sales estimate for Vertex’s suzetrigine falls well short of the prediction for the company’s other trendy new drug, list-topper Alyftrek, suzetrigine may still steal some of its cousin’s thunder.
The non-opioid pain candidate is a NaV1.8 inhibitor designed to block pain signals in the sodium channel, and its approval would make for “the first novel pain mechanism to reach the market for decades,” per Evaluate.
Suzetrigine’s application in moderate to severe acute pain was granted priority review by the FDA, with a target action date set for Jan. 30.
Phase 3 data that Vertex shared last year showed suzetrigine meeting its primary endpoints by significantly improving pain levels over placebo in the 48 hours after patients underwent tummy tucks and bunionectomies, with a clean safety profile.
However, the drug failed to meet a secondary endpoint that pitted it against Vicodin, the widely used (and frequently abused) opioid medication. Though suzetrigine offered a numerical advantage over Vicodin among the tummy tuck patients, it fell short of statistical significance in that group. In the bunion surgery trial, patients treated with Vicodin experienced greater pain relief than those who received suzetrigine.
Still, armed with the primary endpoint wins, Vertex has plowed ahead with suzetrigine in acute pain. Analysts have predicted a favorable launch for the drug, with Leerink Partners setting its 2026 sales estimate at a whopping $866 million.
During Vertex’s presentation at the 2025 J.P. Morgan Healthcare Conference, the company confirmed that it is “launch ready,” with plans to begin rolling out suzetrigine across the U.S. as soon as FDA approval is secured.
Preparing for that rollout has included discussions with government and commercial payers and with retail pharmacy chains, according to Chief Operating Officer Stuart Arbuckle.
“Once a patient gets a prescription for it and they turn up at their retail pharmacy, we certainly want to make sure the product is there,” he said. “These patients are in acute pain—if the product isn’t on the shelves, they’re going to abandon that prescription and get a prescription for something else.”
Though Vertex has yet to announce a list price for suzetrigine, Arbuckle discussed the considerations that go into the setting that price during the JPM presentation.
“We want to make sure that we are pricing it in that sweet spot that allows us to get access for patients, whilst at the same time reflects the clinical value of suzetrigine, the cost offsets that it will have in terms of reducing the opioid epidemic here in America, but also reflects the significant investment we’ve made over literally decades to get to this point,” he said.
In terms of access, Vertex is expected to be helped along in the U.S. by the recently passed Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, which is aimed at encouraging the use of non-opioid pain management approaches for Medicare patients in clinical settings.
While it awaits a decision on suzetrigine in acute pain, Vertex is also in the process of advancing the candidate in chronic pain, with studies ongoing on diabetic peripheral neuropathy and lumbosacral radiculopathy.
A recent update in the latter use case spooked some investors and caused a lasting dip in the company’s stock, as phase 2 results incidentally showed that suzetrigine performed similarly to placebo, though that wasn’t the intended comparator of the study.
4. Aficamten
Company: CytokineticsUsed for: Hypertrophic cardiomyopathy
Est. 2030 sales: $2.8 billion
There was a time about a year ago when aficamten’s entry on this list would’ve opened with “Company: Novartis.” But talks of a takeover of Cytokinetics collapsed at the last minute, leading the South San Francisco biotech to mount a solo challenge to Bristol Myers Squibb’s rival cardiac myosin inhibitor Camzyos in the U.S. and Europe.
Novartis was only named as the interested buyer in media reports, but Cytokinetics CEO Robert Blum has admitted that talks with a potential buyer reached an advanced stage, using this month’s J.P. Morgan Healthcare Conference to report that “we thought we had agreed on a deal,” but it “did not happen for reasons we don’t know.” After seeing the deal collapse, Cytokinetics raised more than $1 billion to fund commercialization.
The biotech has filed for approval of aficamten for obstructive hypertrophic cardiomyopathy in the U.S., where the FDA is set to make a decision by late September, and in Europe. Cytokinetics plans to commercialize aficamten itself in those two markets. Sanofi has the rights to aficamten in China, where the asset could win approval this year, and Bayer is handling Japan.
Blum has acknowledged that biotechs new to selling drugs often disappoint, quoting McKinsey data showing only 20% to 30% of first-time commercial companies exceed launch expectations. Established companies, for their part, exceed expectations 40% to 50% of the time. The CEO made the case that Cytokinetics can be one of the winners by comparing the characteristics of his biotech and successful first-time launchers.
“These are companies that have concentrated customer segments. These are companies that have high profit margins, payer leverage. These are companies that produce bespoke patient experience, rely on omnichannel micromarketing to ensure lean sales and marketing infrastructure,” Blum said. “Cytokinetics has ... been investing for two to three years already in just those very same tenets.”
Cytokinetics plans to hire 125 to 150 sales reps in the U.S. this year. Though the reps will target a market already served by Camzyos, the drug BMS acquired in its $13 billion takeover of MyoKardia, Blum said it’s “not important that we compete with the current entrant.” Rather, the CEO wants to reach “the over 80% of patients who are diagnosed, symptomatic, eligible for treatment and not yet receiving treatment.”
That said, Cytokinetics is bullish about its ability to compete. According to Blum, “We can reasonably anticipate a majority of market share based on the differentiating features.”
Cytokinetics believes its drug candidate has an edge over Camzyos in terms of efficacy, speed of onset and safety. Work to communicate those differences will ramp up post-approval, but the company’s near-term focus is on disease awareness efforts aimed at physicians and patients.
None of this comes cheap. Cytokinetics told investors to expect $440 million to $470 million of operating spend in 2024, and Blum said the figure will “go up as we go to market with aficamten later this year.” The money is funding commercial preparations and further development of aficamten.
Cytokinetics is set to post phase 3 data from a trial that is comparing aficamten to a beta blocker in the first half of 2025.
Insmed currently markets one drug, Arikayce, but the company could have a potential blockbuster on its hands with brensocatib. LunaKate/Getty Images
5. Brensocatib
Company: InsmedUsed for: Neutrophil-mediated diseases
Est. 2030 sales: $2.8 billion
A Fierce Pharma analysis found that smaller companies overshadowed Big Pharma’s presence on the list of FDA drug approvals in 2024. Among those angling to join the ranks of smaller, lesser-known biotechs making an outsized splash on the industry is Insmed, which closed out 2024 by submitting an application to the FDA for its brensocatib in non-cystic fibrosis bronchiectasis, a lung disease.
With the submission now under regulatory review, Insmed said in a presentation at January’s J.P. Morgan Healthcare Conference that it’s expecting to begin brensocatib’s launch in the third quarter of this year, pending the granting of priority review and, of course, the agency’s ultimate sign-off.
In the meantime, Insmed is also planning to submit additional applications this year in the EU, the U.K. and Japan, where it’s aiming to begin commercial rollouts next year should brensocatib earn green lights in each region.
Bronchiectasis is a chronic condition in which the walls of the airway widen and thicken due to inflammation and infection. It’s estimated to affect between 350,000 and 500,000 adults each year in the U.S. alone. According to Insmed, an FDA nod would make brensocatib the first approved treatment for bronchiectasis as well as the first approved dipeptidyl peptidase 1 (DPP1) inhibitor.
The drug hugely impressed investors and analysts alike last year, when Insmed shared phase 3 results showing a major win in the primary endpoint of reducing pulmonary exacerbations. Among more than 1,700 patients split into two dosage groups, those in the 10-mg group experienced a 21% reduction in exacerbations compared with placebo, while patients in the 25-mg group saw a 19% reduction.
Alongside additional wins in several of the trial’s secondary endpoints, patients taking brensocatib also experienced fewer treatment-emergent adverse events than those assigned to the placebo group.
While Insmed awaits a decision on the use of brensocatib in bronchiectasis, the biotech is also forging ahead in applying the drug to a variety of other neutrophil-mediated diseases, a group of inflammatory conditions that are affected by the activity of the most common type of white blood cell and which includes diabetes, lupus, multiple sclerosis, rheumatoid arthritis and more.
As a DPP1 inhibitor, brensocatib is designed to inhibit an enzyme that activates neutrophil serine proteases (NSPs) in white blood cells. Though NSPs normally help mediate inflammation and destroy pathogens, in certain diseases, they’re activated to excess, leading to inflammation and the destruction of organs.
A phase 2b trial of brensocatib in chronic rhinosinusitis without nasal polyps has completed almost 70% of its target enrollment, and top-line data are expected before the end of this year, Insmed said at the JPM conference. In December, the company randomized the first participant in a separate phase 2 trial of the drug in hidradenitis suppurativa.
Evaluate has predicted brensocatib sales could reach $2.8 billion by 2030. That would be a major boon for Insmed, which currently markets only one approved drug, Arikayce, and is expecting to report full-year 2024 revenues of just over $363 million.
Sanofi initially picked up the BTK inhibitor in its $3.7 billion acquisition of Principia Biopharma in 2020. Sanofi
6. Tolebrutinib
Company: SanofiUsed for: Multiple sclerosis
Est. 2030 sales: $1.4 billion
It’s been a long, winding road for tolebrutinib, but Sanofi is finally nearing a potential FDA approval.
The French pharma initially picked up the BTK inhibitor in its $3.7 billion acquisition of Principia Biopharma in 2020. The buyout gave Sanofi full ownership over tolebrutinib, which it had developed in partnership with Principia and which it planned to quickly move into several phase 3 trials.
In 2022, however, the FDA placed a partial clinical hold on phase 3 trials of tolebrutinib in MS and myasthenia gravis after reported cases of drug-induced liver injury. By early 2023, Sanofi had made the decision to scrap the myasthenia gravis program while continuing on in MS.
The drug’s competitors have faced similar setbacks, with Roche’s fenebrutinib and Merck KGaA’s evobrutinib, for example, both facing partial clinical holds in recent years, both also due to liver toxicities. Merck ultimately decided to drop evobrutinib last year after it failed to beat Sanofi’s Aubagio in a pair of MS trials.
And though Sanofi recently reported fails in two of three MS trials of tolebrutinib, the med still appears to have pulled ahead in the race, as it became in December 2024 the first BTK inhibitor for MS to earn breakthrough therapy designation from the FDA, potentially speeding up its regulatory review.
Sanofi is set to submit tolebrutinib for FDA approval in non-relapsing secondary progressive multiple sclerosis (nrSPMS). In the breakthrough therapy designation announcement, the company confirmed that regulatory submissions were “currently being finalized for the US and prepared for the EU.”
During a presentation at the J.P. Morgan Healthcare Conference at the start of this year, Sanofi executives played coy about the exact timeline of the FDA submission, but R&D head Houman Ashrafian, M.D., Ph.D., noted, “Tolebrutinib will launch likely in SPMS this year—subject to regulatory review and approval, but that’s our confidence and our aspiration—and later in the year, [primary progressive MS] will follow.”
Evaluate is forecasting 2030 sales of $1.4 billion for the drug, which, if approved, would become the first disease-modifying therapy specifically indicated to treat nrSPMS.
Ashrafian suggested during the JPM presentation that the sizable unmet need in both primary and secondary progressive MS will allow Sanofi to “have a nice smooth growth dynamic” with tolebrutinib and take “a meaningful chunk of this $23 billion market.”
According to Sanofi, the breakthrough therapy designation was based on the results of its HERCULES phase 3 trial in nrSPMS, in which tolebrutinib was shown to delay the time to onset of six-month confirmed disability progression by 31% compared to placebo.
The company noted that just over 4% of patients in the tolebrutinib group experienced liver enzyme elevations compared to 1.6% in the placebo group, though all but one of the cases resolved without further medical intervention.
Sanofi unveiled the HERCULES trial results in early September, when it also reported a pair of fails in phase 3 trials of tolebrutinib in relapsing MS. In both of those GEMINI trials, the BTK inhibitor failed to outperform approved med Aubagio in terms of reducing relapses, though Sanofi did highlight a “considerable delay” in disability onset among the tolebrutinib group.
Eli Lilly owns the rights to mazdutide outside of China. iStock / Getty Images Plus
7. Mazdutide
Company: Innovent/Eli LillyUsed for: Type 2 diabetes and obesity
Est. 2030 sales: $1.3 billion
Eli Lilly’s wildly successful GLP-1 drug discovery engine is poised to deliver another blockbuster. But, this time around, Innovent is set to be the near-term beneficiary, with the Chinese biotech awaiting approvals for the dual GLP-1/glucagon receptor agonist mazdutide in two indications in its home territory.
Innovent secured Chinese rights to mazdutide in 2019. Last year, the biotech reported two phase 3 wins, leading to filings for approval in China to aid in weight management for adults with obesity or who are overweight and in glycemic control for adults with Type 2 diabetes. The filings could secure the first global approvals for mazdutide and establish the molecule as a challenger for the Chinese GLP-1 market.
If approved, mazdutide will become the first dual GLP-1/glucagon receptor agonist for use in diabetes and obesity. Activating the glucagon receptor may increase energy expenditure, driving changes in the liver, brain and white and brown adipose tissue that complement the reduced energy intake triggered by GLP-1 activation. Innovent reported 18.6% weight loss at Week 48 in a trial of Chinese adults.
Work to expand the anticipated label of mazdutide is already underway. Innovent is running a late-phase trial of a 9-mg dose in obesity, having initially filed for approval of a 6-mg dose. Another late-phase trial is pitting the drug candidate against Novo Nordisk’s semaglutide—the active ingredient in Ozempic and Wegovy—in people with Type 2 diabetes and obesity.
Late-phase trials in obesity with metabolic dysfunction-associated steatotic liver disease, adolescent obesity and obstructive sleep apnea are at the planning stages. Innovent’s earlier-stage pipeline includes studies in metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction.
The expansion into MASH is underpinned by a study that linked mazdutide to an 80% reduction in liver fat at Week 48. Speaking at the J.P. Morgan Healthcare Conference in January, Innovent CEO Michael Yu, Ph.D., said the data were “way better than the FDA approval for MASH,” referring to Madrigal’s Rezdiffra, which earned the FDA’s first approval in the indication last year. Yu said he views mazdutide as a way to improve metabolism and make people healthier rather than just as a weight loss drug.
Innovent spent 2024 working to expand its cardiovascular and metabolism team in preparation for the launches of mazdutide and teprotumumab, the thyroid eye disease therapy that Amgen sells outside of China as Tepezza.
Lilly owns the rights to mazdutide outside of China, but how far the Big Pharma takes the candidate will depend on its ability to clear the bar set by tirzepatide, the active ingredient in Mounjaro and Zepbound. The prospects for mazdutide at Lilly could become clearer this year, with a phase 2 trial of the asset set to wrap up in the coming months. Lilly has recruited 179 patients for the trial, mainly using U.S. sites.
Up first for GSK's depemokimab are expected regulatory filings in severe asthma and chronic rhinosinusitis with nasal polyps. GSK
8. Depemokimab
Company: GSKUsed for: Severe allergic asthma
Est. 2030 sales: $1.2 billion
GSK is expecting depemokimab to do quite a number for its IL-5 franchise—and Evaluate’s sales estimates seem to back up that prediction.
At the J.P. Morgan Healthcare Conference in San Francisco this month, depemokimab made the “major value unlock” tier of GSK’s list (PDF) of five anticipated approvals for 2025. As CEO Emma Walmsley explained in a presentation, between the expected FDA nod for depemokimab and a potential label expansion into chronic obstructive pulmonary disease (COPD) for Nucala, the company has placed the IL-5 franchise’s peak sales potential at more than 4 billion pounds sterling ($4.9 billion).
Depemokimab is a monoclonal antibody that blocks human interleukin-5 (IL-5) from binding to its receptor. It’s aimed at eosinophilic-associated diseases, which occur when the body releases too many eosinophils, a type of white blood cell, leading to inflammation and tissue damage.
The long-acting med requires dosing only every six months—quite the improvement over competitors like Sanofi and Regeneron’s Dupixent, Novartis’ Xolair and GSK’s own Nucala, the typical dosing schedules for which all fall within the two- to four-week range. Per GSK, nearly 90% of patients have indicated that they would prefer a six-month dosing regimen.
Walmsley suggested that, to start, the expected launch of depemokimab could create a “step change” in treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Only one-third of potential asthma patients are currently being treated with biologics, according to GSK research.
“This medicine will not only provide patients with a twice-yearly dosing option, but we believe it will also expand the entire market for asthma biologics," she explained.
Though GSK hasn’t confirmed the submission of an application for depemokimab to U.S. regulators, while sharing data from several phase 3 trials of the drug last fall, the company said results of all four studies "will be used in regulatory filings around the world.”
Those studies included two each in severe asthma and CRSwNP. In severe asthma, the SWIFT-1 and SWIFT-2 trials enrolled a combined 760 adults and adolescents with severe asthma and type 2 inflammation. Over the course of a year, depemokimab was shown to reduce asthma exacerbations by 54% compared to placebo.
Results on the secondary endpoints, however, were more mixed. The experimental group experienced a 72% reduction in clinically significant exacerbations that required hospitalization or a visit to an emergency department, but the drug was less successful when pitted against the placebo group in terms of quality of life, asthma control and how much air a patient could exhale.
Kaivan Khavandi, M.D., Ph.D., GSK’s global head of respiratory/immunology R&D, confirmed to Fierce Biotech at the time that the secondary misses wouldn’t “alter the strategy at all,” as “it’s well recognized that the most important clinical outcome to prevent is exacerbations.”
Meanwhile, in the ANCHOR-1 and ANCHOR-2 trials of 528 patients with CRSwNP, depemokimab achieved both primary endpoints: improving the total endoscopic nasal polyp score at 52 weeks and the mean nasal obstruction score from weeks 49 to 52 compared to placebo.
Following closely behind depemokimab’s efforts in severe asthma and CRSwNP, phase 3 trials are also ongoing in eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome. Plus, according to Walmsley’s presentation at JPM, GSK is planning to begin a phase 3 trial of depemokimab in COPD sometime this year.
GSK is aiming to generate peak sales of around $2.4 billion across its portfolio of meningitis vaccines. GSK
9. Meningococcal ABCWY vaccine
Company: GSKUsed for: Meningococcal A, B, C, W-135 and Y vaccine
Est. 2030 sales: $1.2 billion
GSK is poised to open a new front in its tussle with Pfizer for the meningococcal disease vaccine market. The British company already sells vaccines against meningococcal A, C, W-135 and Y and meningococcal B. With GSK-3536819, GSK has combined Menveo and Bexsero’s antigenic components into one vaccine.
The FDA is set to decide whether to approve GSK’s five-in-one vaccine candidate by Feb. 14. If the agency shows its love for GSK-3536819 on Valentine’s Day, the pentavalent vaccine will enter a market already served by Pfizer’s Penbraya. The FDA approved Penbraya in 2023. Like GSK, Pfizer also sells two separate vaccines, Nimenrix and Trumenba, that together cover the same five components as its pentavalent shot.
GSK is aiming to generate peak sales of around 2 billion pounds sterling ($2.4 billion) across its portfolio of meningitis vaccines. The company’s existing portfolio pulled in 1.1 billion pounds over the first nine months of 2024, driven by Menveo and, in particular, Bexsero.
Launching the pentavalent vaccine could boost growth of the portfolio, building on the 16% increase in sales reported over the first nine months of 2024. However, questions about exactly how the five-in-one shots will fit into vaccination schedules in the long term remain unanswered.
In 2023, the U.S. Advisory Committee on Immunization Practices (ACIP) said Pfizer’s Penbraya may be given to people aged 10 years and up when a quadrivalent and meningococcal B vaccine are indicated at the same visit. The recommendations also detailed a standard three-dose regimen for those in need of protection against all five bacteria types, with patients receiving a quadrivalent shot starting at age 11 and then, starting at age 16, either a second quadrivalent dose plus a meningococcal B vaccine or a dose of a pentavalent shot followed six months later by another meningococcal B shot.
Following the recommendations, an analyst asked (PDF) Pfizer, “If the [pentavalent] vaccine is effectively only used for dose two of three, does that significantly reduce the commercial opportunity you had anticipated?”
In response, Angela Hwang, then Pfizer’s chief commercial officer, said the company could share more data with the ACIP in 2024, giving it “a second bite of the apple, which will allow us to achieve our peak sales”—though, to date, the 2023 recommendations are still in place.
Pfizer has yet to start breaking out sales of Penbraya. In the third quarter of 2024, the company included (PDF) meningococcal vaccine revenues among the $652 million made by multiple unnamed primary care products. Nimenrix and Trumenba, Pfizer’s quadrivalent and meningococcal B vaccines, generated $179 million and $126 million, respectively, in 2023.
GSK has a bigger meningococcal vaccine business, but, as with Pfizer’s Penbraya, uptake of its pentavalent shot will be shaped by ACIP recommendations. The case for the five-in-one shots rests on their potential to reduce the number of injections patients receive and to increase the number of people with protection against all the bacterial strains.
Approval in generalized myasthenia gravis could be the start of a series of authorizations for nipocalimab. Angus Liu/Fierce Pharma
10. Nipocalimab
Company: Johnson & JohnsonUsed for: Myasthenia gravis and other autoimmune disorders
Est. 2030 sales: $1.2 billion
Nipocalimab represents a major bet by Johnson & Johnson. The Big Pharma acquired the asset in its $6.5 billion takeover of Momenta Pharmaceuticals in 2020 and proceeded to run a broad R&D program to validate its belief that FcRn blockade represents a “pipeline in a pathway.” In 2025, J&J could start recouping some of its outlay.
The FDA accepted an application for approval of nipocalimab in generalized myasthenia gravis (gMG) for priority review in early 2025. J&J secured the truncated path to market for the antibody despite the availability of other FcRn blockers: argenx won FDA approval for its FcRn drug Vyvgart in 2021 and later bagged OKs for a subcutaneous version in two indications, and UCB’s Rystiggo entered the fray in 2023.
J&J is positioned to secure a broader label than argenx or UCB. Argenx won FDA approval in people who are positive for anti-AChR antibodies, while UCB’s label covers patients with antibodies against AChR or MuSK. J&J went one better by enrolling people with antibodies against AChR, MuSK and LRP4.
The inclusion criteria have enabled J&J to pitch nipocalimab as a treatment for the broadest population of gMG patients and to secure priority review. However, most gMG patients are already eligible for treatment with Vyvgart and Rystiggo, as anti-AChR antibodies are found in up to 90% of gMG patients. The LRP4-positive patients that differentiate the J&J trial account for up to 5% of cases.
Approval in gMG could be the start of a series of authorizations for nipocalimab. J&J is running phase 3 trials in hemolytic disease of the fetus and newborn, warm autoimmune hemolytic anemia and chronic inflammatory demyelinating polyneuropathy. The roster of phase 2 trials includes studies in rheumatoid arthritis, systemic lupus erythematosus and Sjogren’s disease.
The broad R&D program is built on evidence that blocking FcRn cuts levels of circulating immunoglobulin G (IgG) antibodies without impacting other immune functions. IgG antibodies mediate a wide range of autoimmune diseases, leading J&J and its rivals to conclude that FcRn blockade is a “pipeline in a pathway.”
However, argenx’s stuttering efforts to expand beyond gMG have raised doubts about just how broadly FcRn drugs can be used, with the biotech chalking up failures for its subcutaneous formulation in a bleeding disorder and a group of chronic blistering diseases in 2023. The company is studying its intravenous product in the bleeding disorder—immune thrombocytopenia—and is on course to report data next year.
UCB is also testing Rystiggo in other indications, and Immunovant is studying its investigational FcRn prospect in gMG, Graves’ disease, thyroid eye disease and chronic inflammatory demyelinating polyneuropathy. J&J’s target indications could keep nipocalimab clear of rival FcRn blockers in some settings, but it will face competition from drugs with different mechanisms in conditions such as rheumatoid arthritis.
Read More: https://www.fiercepharma.com/marketing/top-10-most-anticipated-drug-launches-2025
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