FDA Asks GSK for More Evidence of Mepolizumab’s Ability to Help Treat Flares in COPD Patients
GlaxoSmithKline’s application for approval of mepolizumab as an add-on therapy to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD) requires more clinical data, the U.S. Food and Drug Administration (FDA) said in a complete response letter. GSK sought approval for mepolizumab as an add-on to inhaled corticosteroid-based maintenance treatments used…