Bosatria mepolizumab: Phase III data

The double-blind, international Phase III MEA115575 trial in 135 patients with severe eosinophilic asthma on regular treatment with oral corticosteroids, high-dose inhaled corticosteroids and an additional controller medication showed that 100 mg subcutaneous mepolizumab given every 4 weeks for up to 20 weeks met the primary endpoint of a greater reduction from baseline in maintenance oral corticosteroid dose during weeks 20-24 while maintaining asthma control vs. placebo (p=0.008). Adverse events were similar across treatment arms. The most common adverse events were headache, nasopharyngitis, bronchitis, sinusitis, fatigue 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. ...