GSK's Twice-Yearly Depemokimab Reduces Nasal Polyp Size, Goes Under FDA Review

Core Insights - The FDA has accepted GSK's marketing application for depemokimab for two indications, with topline data expected in October 2024 [1] Group 1: Indications and Treatment - The proposed indications for depemokimab include add-on maintenance treatment for asthma in patients aged 12 and older with type 2 inflammation and as add-on maintenance treatment for adults with inadequately controlled chronic rhinosinusitis with nasal polyps [2] - The Prescription Drug User Fee Act (PDUFA) date for GSK's application is set for December 16, 2025 [3] Group 2: Clinical Trial Results - The ANCHOR-1 (N=271) and ANCHOR-2 (N=257) phase 3 trials met their co-primary endpoints, showing significant improvements in nasal polyp size and nasal obstruction with depemokimab compared to placebo [4] - A pooled analysis indicated that treatment benefits were observed from the first assessment and sustained to week 52 [4] - In secondary endpoints, depemokimab showed nominally significant improvements over placebo, with 88% of treated patients not requiring surgery or disease-modulating medication compared to 83% in the placebo group [5] Group 3: Market Reaction - Following the announcement, GSK's stock increased by 2.04%, reaching $38.36 [5]