An injection drug for treating patients with eosinophilic asthma is safe and effective for adults, according to an FDA advisory committee.
Members of the Pulmonary–Allergy Drugs Advisory Committee voted 14-0 to approve mepolizumab in adults age 18 years and older. However, the group voted 10-4 against approving the drug for use in adolescents.
Phase III studies showed that the drug reduced exacerbations and daily oral corticosteroid needs in patients with severe eosinophilic asthma.
GlaxoSmithKline is seeking approval for the drug in patients age 12 years and older who have severe asthma with high blood eosinophil counts. Mepolizumab, a monoclonal antibody targeting interleukin-5 receptors, would be administered by subcutaneous injection every four weeks.
If approved, mepolizumab would be the first noninhaled drug in the treatment of asthma.
SILVER SPRING, Md. — A novel injection drug aimed at eosinophilic asthma is safe and effective for adults, an FDA advisory committee decided Thursday, but the panel did not support approving the drug for adolescents. Members of the Pulmonary-Allergy Drugs Advisory Committee voted 14-0 that the overall data supported approval in adults 18 and older.
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