GSK's Nucala for COPD and Depemokimab for Asthma Get CHMP Nod in EU

Core Insights - GSK plc announced a positive opinion from the CHMP of the EMA recommending the approval of Nucala as an add-on maintenance treatment for COPD [1] - The European Commission's final decision on Nucala is expected in early 2026, which could provide a new treatment option for millions of Europeans with uncontrolled COPD [2] - GSK's shares have increased by 45.3% over the past year, outperforming the industry average rise of 12.4% [4] Product Details - Nucala is a monoclonal antibody targeting IL-5, a key cytokine in type 2 inflammation, and was approved for COPD treatment in the U.S. in May 2025 [5] - GSK markets Nucala for four other IL-5-mediated conditions, including severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps [6] Additional Developments - The CHMP also recommended approval for depemokimab, an investigational ultra-long-acting IL-5-targeting biologic for severe asthma and CRSwNP, with a final decision expected in Q1 2026 [7] - Depemokimab is under review in the U.S. for the same indications, with a decision anticipated soon [8] Clinical Data - The positive opinion for Nucala is supported by data from phase III studies demonstrating its efficacy in reducing hospital visits for COPD patients [10] - Depemokimab showed sustained efficacy with a twice-yearly dosing regimen, indicating potential for ultra-long-acting protection from asthma exacerbations [10]