According to Healio, an FDA advisory committee has voted in favor of approving Nucala (mepolizumab, GlaxoSmithKline) for the treatment of severe asthma in adults 18 years and older.
An FDA advisory committee today voted unanimously in favor approving of Nucala for the treatment of severe asthma with eosinophilic inflammation in individuals aged 18 years and older.
However, the committee members voted against recommending use of the therapy in adolescents aged 12 to 17 years by a vote of 4-10.
The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 14-0 in favor of approving Nucala (mepolizumab, GlaxoSmithKline) in adults.
Twelve members from the committee voted safety of mepolizumab 100 mg subcutaneously (SC) administered once every 4 weeks in children aged 12 to 17 years had not been adequately demonstrated for treatment of severe asthma.
And nine of the committee members voted that efficacy data did not provide substantial evidence of a meaningful benefit of mepolizumab 100 mg SC once every 4 weeks for the treatment of severe asthma in children aged 12 to 17 years.