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FDA Advisory Committee Splits on COPD Indication for GlaxoSmithKline Drug
Drugs Regulatory Affairs
An advisory panel Wednesday recommended that the FDA collect more data before signing off on use of GlaxoSmithKline’s asthma drug mepolizumab for treating chronic obstructive pulmonary disease (COPD).
The Pulmonary-Allergy Drugs Advisory Committee considered GSK’s supplemental biologics license application for mepolizumab as an add-on to inhaled corticosteroid-based maintenance treatment to reduce COPD flares.
In a 16-3 vote, members called for more data, possible further trials and more precise distinctions between COPD and asthma before they could endorse its efficacy.