News from the FDA/CDC

Benralizumab approved for eosinophilic asthma


The monoclonal antibody benralizumab has been approved by the FDA for use as add-on maintenance therapy for eosinophilic asthma patients aged 12 years and older, AstraZeneca announced Nov. 14.

This is the only respiratory biologic to provide fast and “near-complete depletion of eosinophils within 24 hours,” according to the statement from AstraZeneca.

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The Food and Drug Administration’s approval was based on results of the WINDWARD program, including three phase 3 trials involving 8 weeks of benralizumab use. Compared with placebo, benralizumab reduced the annual asthma exacerbation rate by up to 51% and significantly improved lung function, as measured by forced expiratory volume in 1 second. Additionally, a 75% median reduction in daily oral corticosteroid use was seen in patients who took the recently approved respiratory biologic.

Similar adverse events were seen in patients who took benralizumab and the placebo. AstraZeneca will market benralizumab under the trade name Fasenra.

“This is an important day for severe, eosinophilic asthma patients who have had limited treatment options for far too long,” said Eugene Bleecker, MD, professor and codirector of genetics, genomics, and precision medicine at the University of Arizona in Tucson, in the statement.

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