GSK to Present Positive Phase III Data for Long-Acting Asthma Medication to FDA

GSK has announced promising results for its new long-acting asthma treatment, depemokimab, which could potentially generate up to $4 billion in peak sales if approved. The data from the Phase III clinical trials, presented at the European Respiratory Society and published in the New England Journal of Medicine, demonstrate significant benefits for patients with severe asthma.

The trials, named SWIFT-1 and SWIFT-2, involved comparing depemokimab to a placebo in adults and adolescents with severe asthma characterized by type 2 inflammation and high blood eosinophil counts. The studies showed that depemokimab reduced the incidence of severe asthma attacks by 54% and cut down hospitalizations or emergency room visits due to exacerbations by 72%. These findings indicate a statistically significant and clinically meaningful reduction in exacerbations over a 52-week period compared to the placebo.

Despite these positive results, depemokimab did not meet some secondary endpoints related to overall health and quality of life, as well as disease severity assessed by forced expiratory volume. GSK’s global head of Respiratory/Immunology R&D, Kaivan Khavandi, attributed this to a high placebo response in those particular measures. However, he emphasized that the primary goal of reducing severe asthma exacerbations is more crucial and challenging, suggesting that this will not affect GSK's strategic direction.

Depemokimab belongs to the anti–IL-5 class of therapies and is among GSK’s planned major product launches aimed at generating substantial revenue by 2031. If approved, the drug is expected to bring in significant sales, adding to the company's robust pipeline of new treatments. Depemokimab’s twice-yearly injection regimen is designed to improve patient adherence and the durability of treatment, a key factor in managing chronic conditions like severe asthma.

Current treatments for severe asthma include GSK’s Nucala, Teva Pharma’s Cinqair, and AstraZeneca’s Fasenra. Many patients on these existing short-acting biologics discontinue treatment within a year, highlighting the need for more convenient and less burdensome treatment options. Khavandi pointed out that sustained suppression of inflammation is crucial for long-term management of the condition.

GSK is also exploring the use of depemokimab for other conditions, including chronic rhinositis with nasal polyps. The company plans to coordinate its regulatory submission strategy for both indications to maximize the therapeutic potential of depemokimab.

Additionally, the trials revealed structural changes in airway remodeling among the patients treated with depemokimab, suggesting that the drug may be addressing the underlying causes of asthma. This potential to modify the disease at a structural level further strengthens the case for depemokimab as a transformative treatment option.

GSK intends to swiftly present the trial data to regulatory authorities worldwide to accelerate the drug’s approval process. If successful, depemokimab could become a cornerstone of GSK’s respiratory portfolio, offering a new hope for patients with severe asthma.

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