Bosatria mepolizumab regulatory update
FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 14-0 that efficacy and safety data support approval of Bosatria mepolizumab from GlaxoSmithKline to treat severe asthma with eosinophilic inflammation in adults. The panel also voted 10-4 that data do not support approval in patients ages 12-17. The PDUFA date is Nov. 4.
The committee voted 14-0 that the data provided substantial evidence of a clinically meaningful benefit and 13-1 that safety of the humanized IgG mAb against IL-5 has been adequately demonstrated in adults. Panelists voted 9-5 and 12-2 on the same questions for patients ages 12-17 primarily due to the limited number of patients in the age group in the overall database. The panel recommended that further data are needed in this subpopulation. ...