▎WuXiEdited by Kant Content Team
GSK announced today that the U.S. FDA has accepted the Biologics License Application (BLA) for its investigational therapy depemokimab for two indications. These include use as an add-on maintenance treatment for adult and adolescent asthma patients aged 12 years and older with type 2 inflammation (characterized by blood eosinophil count), whose symptoms are not adequately controlled on medium- to high-dose inhaled corticosteroids (ICS) combined with another asthma control medication; and as an add-on maintenance treatment for adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have inadequately controlled disease. The Prescription Drug User Fee Act (PDUFA) date for this application is December 16, 2025.According to the press release, if approved, depemokimab will become the first approved ultra-long-acting biologic that requires dosing only once every 6 months.It is worth mentioning that the therapy was assessed by the industry media Evaluate as有望在2025年获批上市.Potential Blockbuster Therapy！
The application submitted this timeMainBased on the positive data from the SWIFT and ANCHOR projects.Results from the Phase 3 clinical trials SWIFT-1 and SWIFT-2 showed that the trials met the primary endpoint,Depemokimab significantly reduced asthma exacerbations by 54% (RR=0.46, 95% CI:0.36–0.59, p<0.001), these patients have type 2 inflammation characteristics (marked by blood eosinophil count).In addition, the trial also achieved secondary endpoints.Compared with placebo, the clinically significant deterioration requiring hospitalization or emergency treatment was reduced by up to 72%.（HR=0.28，95% CI：0.13–0.61，p=0.002）。
▲InPatients in the SWIFT-1 (upper) and SWIFT-2 (lower) trialsKaplan–Meier Analysis Results of the Time to First Asthma Attack (Image Source: Reference [2])
ANCHOR-1AndANCHOR-2Two identical Phase 3 clinical trials to evaluate depemokimabAs adjunctive therapy in adultsCRSwNPSafety and efficacy in patients.Both studies met their co-primary endpoints, meaning that compared to placebo, patients in the depemokimab group showed significant improvement at week 52.The change in the total nasal polyp score from baseline to the end of the study, as well as the change in the mean Nasal Obstruction Symptom Evaluation (NOSE) scale score from baseline during weeks 49 to 52, both showed statistically significant improvement.Depemokimab is a research-stage ultra-long-acting biologic targeting interleukin-5 (IL-5).Depemokimab can bind to IL-5 with high affinity and is administered once every six months for the treatment of severe asthma patients.IL-5 is a key cytokine in type 2 inflammation.More than 80% of patients with severe asthma have their condition driven by type 2 inflammation, characterized by elevated eosinophil levels and unpredictable exacerbations.▲To learn more about the application of cutting-edge technologies in the biopharmaceutical industry, please long-press and scan the QR code above to access "WuXi AppTec Live Studio" and watch live discussions and exciting replays on related topics.
References:
[1]
Depemokimab applications accepted for review by the US FDA for asthma with type
2 inflammation and for chronic rhinosinusitis with nasal polyps (CRSwNP).
Retrieved March 3, 2025 from https://www.gsk.com/en-gb/media/press-releases/depemokimab-applications-accepted-for-review-by-the-us-fda/
[2] Jackson DJ,
Wechsler ME, Jackson DJ, Bernstein D, Korn S, Pfeffer PE, Chen R, Saito
J, de Luíz Martinez G, Dymek L, Jacques L, Bird N, Schalkwijk S, Smith
D, Howarth P, Pavord ID; SWIFT-1 and SWIFT-2 Investigators. Twice-Yearly
Depemokimab in Severe Asthma with an Eosinophilic Phenotype. N Engl J
Med. 2024 Sep 9. doi: 10.1056/NEJMoa2406673. Epub ahead of print. PMID:
39248309.
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