Bosatria mepolizumab: Phase III data

The double-blind, international Phase III MEA115588 trial in 576 patients with severe eosinophilic asthma with frequent exacerbations despite treatment with high-dose inhaled corticosteroids and >=1 other controller medication showed that 75 mg IV mepolizumab and 100 mg subcutaneous mepolizumab given every 4 weeks for 32 weeks each met the primary endpoint of reducing the frequency of clinically significant asthma exacerbations vs. placebo (p<0.001 for both). Specifically, mepolizumab led to placebo-adjusted reductions of 47% at the low dose and 53% at the high dose. Adverse events reported were similar across all treatment arms. The most common adverse events were nasopharyngitis, headache, upper respiratory tract infection and asthma. The trial enrolled patients with a blood eosinophil count of >=150 cells/µL at initiation of treatment or who have had blood eosinophils of >=300 cells/µL in the past 12 months. By year end, GlaxoSmithKline plans to submit global regulatory applications for mepolizumab to treat severe eosinophilic asthma. ...