{"id":50871,"date":"2025-12-15T22:32:18","date_gmt":"2025-12-15T14:32:18","guid":{"rendered":"https:\/\/flcube.com\/?p=50871"},"modified":"2025-12-15T22:32:21","modified_gmt":"2025-12-15T14:32:21","slug":"gsks-nucala-wins-chmp-nod-for-copd-in-europe","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=50871","title":{"rendered":"GSK’s Nucala Wins CHMP Nod for COPD in Europe"},"content":{"rendered":"\n

UK biopharma GlaxoSmithKline plc<\/strong> (GSK, NYSE: GSK<\/a>) announced that the European Medicines Agency\u2019s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Nucala (mepolizumab)<\/strong> as add\u2011on maintenance therapy for uncontrolled COPD<\/strong> in adults with raised blood eosinophils on triple therapy (ICS\/LABA\/LAMA). The drug was approved for COPD in the US in May\u202f2025.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Details<\/th><\/tr><\/thead>
Recommendation Date<\/strong><\/td>12\u202fDec\u202f2025<\/td><\/tr>
Regulatory Body<\/strong><\/td>CHMP of the European Medicines Agency (EMA)<\/td><\/tr>
Product<\/strong><\/td>Nucala (mepolizumab)<\/td><\/tr>
Indication<\/strong><\/td>Add\u2011on maintenance therapy for uncontrolled COPD in eosinophilic adults on ICS\/LABA\/LAMA<\/td><\/tr>
Mechanism<\/strong><\/td>IL\u20115 monoclonal antibody<\/td><\/tr>
Current EU Approvals<\/strong><\/td>4 indications: severe asthma, CRSwNP, EGPA, HES<\/td><\/tr>
Expected EU Approval<\/strong><\/td>Q1\u202f2026 (EC decision)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical & Market Context<\/h2>\n\n\n\n