GSK has announced that the European Medicines Agency (EMA) has accepted for review its application to expand the use of Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5) as an add-on maintenance treatment for patients with COPD with an eosinophilic phenotype.
The company said in a news release that the application is supported by results from the positive phase 3 MATINEE trial, which showed a statistically significant and clinically meaningful reduction in the annualized rate of moderate to severe exacerbations using mepolizumab compared to placebo.
If approved, Nucala would be the first biologic with monthly dosing for patients with COPD. The drug is currently approved for use in Europe for four IL-5 mediated conditions including two respiratory indications, as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children older than six, and as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps.
Meanwhile, pharmaceutical company Sanofi said in a news release that Dupixent has been approved as the first-ever biologic medicine in Japan for patients with COPD.
Japan’s Ministry of Health, Labor and Welfare has granted marketing and manufacturing authorization for the drug based on data from the landmark BOREAS phase 3 study. The study evaluated Dupixent added to background maximal standard of care therapy in adults with uncontrolled COPD and elevated blood eosinophils. The study showed that Dupixent significantly reduced exacerbations and improved lung function compared to placebo.
The approval marks the first new treatment approach for COPD in Japan in more than a decade and the sixth approved indication for chronic diseases with underlying type 2 inflammation.
