GSK's Mepolizumab Becomes First Monthly Biologic, First IL-5 Drug Approved for COPD in US​

GSK announced the US regulator approved Nucala (mepolizumab) for add-on maintenance treatment of chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. This is the first IL-5 therapy approved for COPD and the first monthly-administered biologic for COPD. The efficacy was confirmed in the Phase III MATINEE study (n=806), where mepolizumab (100 mg every 4 weeks) showed significantly lower annual exacerbation rates versus placebo (0.80 vs 1.01, P=0.01) after 104 weeks. First approved in the US in November 2015 for severe eosinophilic asthma, mepolizumab's indications have expanded to include other respiratory ailments. As the third leading cause of death globally affecting 390 million patients, COPD treatment has been limited to symptom management, making mepolizumab's monthly dosing a significant advancement following dupilumab's biweekly regimen.

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