BioCentury
ARTICLE | Clinical News

FDA panel backs GSK's Bosatria to treat asthma in adults

June 12, 2015 1:06 AM UTC

FDA's Pulmonary-Allergy Drugs Advisory Committee voted 14-0 that efficacy and safety data support approval of Bosatria mepolizumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat severe asthma with eosinophilic inflammation in adults. The committee voted 10-4 that data do not support approval in children aged 12-17.

The committee voted 14-0 and 13-1 that data show clinical efficacy and safety of Bosatria in adults. Members voted 9-5 that data do not show clinical benefit and 12-2 that safety had not been adequately demonstrated in adolescents. ...