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FDA Panel Backs Approval of Asthma Treatment Mepolizumab (Nucala) in Adults
The FDA’s Pulmonary–Allergy Drug Advisory Committee has recommended the approval of mepolizumab (Nucala, GlaxoSmithKline) for severe asthma in patients 18 years of age and older. The panel voted 10 to 4 to recommend against approving the drug for use in children 12 to 17 years of age.
If approved, mepolizumab would be the first new biologic treatment for severe asthma in more than a decade. It is designed to be given once every 4 weeks by subcutaneous (SC) injection.
Mepolizumab is a humanized monoclonal antibody (immunoglobulin G1, kappa, monoclonal antibody) that has been developed as an add-on maintenance treatment for patients with severe asthma with eosinophilic inflammation. Severe asthma is defined as asthma that requires treatment with high-dose inhaled corticosteroids plus a second controller (and/or systemic corticosteroids) to prevent it from becoming uncontrolled or that remains uncontrolled despite this therapy.
Asthma affects more than 22 million people in the U.S., and severe asthma accounts for 5% to 10% of that population.
Five studies provided the primary supportive data for the efficacy and safety of mepolizumab in subjects with severe eosinophilic asthma. Studies 997, 588, and 575, were randomized, double-blind, parallel-group, placebo-controlled trials, and studies 661 and 666 were open-label extension (OLE) trials.
- Study 997 was a 52-week dose-ranging (intravenous [IV] doses of 75, 250, and 750 mg) trial that confirmed the exacerbation-reduction effect of mepolizumab.
- Study 588 reconfirmed the exacerbation-reduction effect of mepolizumab and showed that an IV dose of 75 mg and an SC dose of 100 mg had comparable effects. This 32-week trial also provided efficacy data on quality of life, asthma control, and lung function.
- Study 575, an oral corticosteroid (OCS) reduction trial, evaluated the 100-mg SC dose of mepolizumab. In addition to confirming the ability of mepolizumab to allow the reduction of the daily OCS (prednisone) dose, this 24-week study reported efficacy data for quality of life, asthma control, and lung function.
- OLE studies 666 (approximately 3.5 years; ongoing) and 661 (52 weeks; concluded) enrolled patients who participated in studies 997 and in studies 588 and 575, respectively. These trials provided additional long-term safety data for mepolizumab 100 mg SC, the proposed dose for marketing.