FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Research and Development

GSK Lauds Positive Findings of Phase III Mepolizumab Studies

March 14, 2014
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Two Phase III studies of GlaxoSmithKline’s mepolizumab met their primary endpoints in patients with severe eosinophilic asthma who did not see a reduction in exacerbations with high-dose inhaled corticosteroids and an additional controller drug, the UK drugmaker said Wednesday.

In the double-blind, parallel-group, multicenter, placebo-controlled, randomized MEA115588 study, 576 patients ages 12 and older were given either 75 mg of intravenous mepolizumab or 100 mg of subcutaneous (SC) mepolizumab every four weeks over a total period of 32 weeks.

Some 47 percent of patients in the 75-mg IV treatment arm, and 53 percent of patients in the 100-mg SC treatment arm met the study’s primary endpoint of reductions in exacerbations, GSK said.

In the second double-blind, parallel-group, multicenter, placebo-controlled, randomized study, known as MEA115575, 135 patients ages 12 and older were given 100 mg of SC mepolizumab every four weeks over a total period of 24 weeks. This study met its primary endpoint of reducing oral corticosteroid use while maintaining asthma control during weeks 20-24.

The drugmaker has multiple compounds in its pipeline for asthma, though spokeswoman Melinda Stubbee told Drug Daily Bulletin Thursday that mepolizumab, an investigational, fully humanized IgG1 IL-5-specific monoclonal antibody, is its first non-inhaled asthma treatment.

The company plans to file for regulatory approval for mepolizumab worldwide later this year.

GSK is also studying the drug in COPD and eosinophilic granulomatosis with polyangiitis. — Lena Freund

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