EMA Accepts GSK's Filing for Depemokimab in Two Respiratory Diseases

Core Viewpoint - GSK has announced that the European Medicines Agency (EMA) has accepted its regulatory filing for the IL-5 inhibitor depemokimab, targeting asthma with type II inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP) [1][2]. Group 1: Regulatory Filings and Approvals - The submission for asthma is aimed at individuals aged 12 and older, while the CRSwNP submission targets adults [2]. - Similar regulatory filings have been validated for review in China and Japan [2]. - If approved, depemokimab will be the first ultra-long-acting biologic requiring only one dose every six months [2]. Group 2: Clinical Data and Efficacy - GSK's regulatory filings are backed by positive data from late-stage programs SWIFT and ANCHOR [5]. - The SWIFT studies met co-primary endpoints, showing a statistically significant reduction in nasal polyp size and nasal obstruction compared to placebo at 52 weeks [5]. - The ANCHOR studies also met primary endpoints, demonstrating significant reductions in asthma exacerbations over 52 weeks compared to placebo [6]. Group 3: Mechanism and Additional Indications - Depemokimab targets IL-5, a key protein in type II inflammation, which affects patients with difficult-to-treat asthma and is present in up to 80% of CRSwNP patients [7]. - The drug is also being evaluated in late-stage studies for other IL-5-mediated diseases, including eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES) [8]. Group 4: Competitive Landscape - If approved, depemokimab will face competition from Sanofi and Regeneron's Dupixent, which is already approved for multiple type II inflammatory diseases [9]. - Dupixent's label was recently expanded by the FDA to include adolescent patients aged 12 to 17 for CRSwNP [10]. - GSK's drug may also compete with AstraZeneca's Fasenra, which is approved for eosinophilic asthma and EGPA, and is being evaluated for COPD and HES [10]. Group 5: Stock Performance - GSK shares have declined by 10% over the past year, compared to an 11% decline in the industry [3].