The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion of AstraZeneca's and MedImmune's benralizumab, which is designed to treat adults with severe eosinophilic asthma.
“This positive recommendation is an important step towards providing a next-generation treatment for severe, uncontrolled asthma patients with an eosinophilic phenotype,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in a press release. “Benralizumab has the potential to make a real difference to patients with its combination of efficacy, speed of onset, convenience and the ability to reduce oral steroid use.”
The European Commission will now review the CHMP opinion, according to the release. The commission will determine whether to approve the medicine for the 28 European Union member countries plus Iceland, Liechtenstein and Norway. The United States, Japan and other countries are also reviewing the drug.
“Severe, uncontrolled asthma affects millions of people around the world, and many patients experience debilitating symptoms and face increased risk of hospitalizations, emergency room visits and death despite current treatments,” Tim Harrison, professor of asthma and respiratory medicine at the University of Nottingham and CALIMA trial investigator, said in the release.