FDA Committee Recommends GSK Respiratory Drug for Certain Uses
GlaxoSmithKline (GSK) received mixed opinions from the Pulmonary Allergy Drugs Advisory Committee of the US Food and Drug Administration (FDA) regarding the company’s biologics license application (BLA) for mepolizumab as an add-on maintenance treatment for severe asthma with eosinophilic inflammation.
The FDA Advisory Committee voted unanimously that the efficacy and safety data for mepolizumab, an anti IL-5 monoclonal antibody delivered as a 100 mg fixed dose via a subcutaneous injection every four weeks, supported approval in adults 18 years of age and older with severe asthma. The committee also voted that the efficacy data provided substantial evidence of a clinically meaningful benefit in this population, and safety in adults with severe asthma had been adequately demonstrated.
The committee, however, voted against approval of mepolizumab for use in adolescents 12-17 years of age with severe asthma. It recommended that further data are needed in this sub-population where there is a high unmet need.
FDA Advisory Committees provide non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. The Prescription Drug User Fee Act (PDUFA) goal date for mepolizumab is November 4, 2015.
The BLA for mepolizumab was submitted to the FDA in November 2014 for approval as an add-on maintenance treatment for patients with severe asthma with eosinophilic inflammation, identified by a blood eosinophil count of at least 150 cells per microliter at the start of treatment or 300 cells per microliter in the past 12 months.Regulatory filings in a number of other countries, including the European Union and Japan, are underway. Further submissions are planned during the course of 2015, according to GSK.