AstraZeneca and its Maryland-based biologics research and development arm, MedImmune, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending benralizumab as an add-on maintenance treatment in adult patients with a type of severe asthma.
Sean Bohen, executive vice president, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “This positive recommendation is an important step towards providing a next-generation treatment for severe, uncontrolled asthma patients with an eosinophilic phenotype. 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 endorsement came after late-stage trials.
Tim Harrison, professor of Asthma and Respiratory Medicine, University of Nottingham, UK, said: “Severe, uncontrolled asthma affects millions of people around the world, and many patients experience debilitating symptoms and face an increased risk of hospitalizations, emergency room visits and death despite current treatments. Benralizumab is a new kind of precision antibody with proven efficacy and ease of use which will help transform severe asthma care.
The positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the 28 EU member countries plus Iceland, Norway and Liechtenstein.
Benralizumab is also under regulatory review in the US, Japan and several other countries.
The endorsement was good news for AZ, which has seen its share of disappointments with asthma drugs, a key focus of its development efforts.
AstraZeneca employs upwards of 1,500 in administration and logistics areas in northern Delaware.