FDA Clears Benralizumab for Severe Eosinophilic Asthma

Megan Brooks


November 15, 2017

The US Food and Drug Administration (FDA) has approved benralizumab (Fasenra, AstraZeneca) as adjunctive maintenance treatment for adults and children aged 12 years and older with severe eosinophilic asthma, the company has announced.

Benralizumab is an antieosinophil humanized monoclonal antibody that selectively targets the interleukin-5 receptor expressed on the surface of eosinophils. It's the only respiratory biologic that provides "direct, rapid and near-complete depletion of eosinophils within 24 hours," the company said in a news release.

Benralizumab will be available as a fixed-dose subcutaneous injection via a prefilled syringe. The recommended dose is 30 mg every 4 weeks for the first three doses, followed by once every 8 weeks thereafter.  Benralizumab is the first respiratory biologic with an 8-week dosing schedule, the company said.

The FDA approved benralizumab based on three phase 3 studies, which demonstrated the following:

  • Up to 51% reduction in the annual asthma exacerbation rate vs placebo;

  • Significant improvement in lung function as measured by forced expiratory volume in 1 second of up to 159 mL vs placebo, with differences seen as early as 4 weeks after the first dose;

  • 75% median reduction in daily oral corticosteroid use and discontinuation of oral corticosteroid use in 52% of eligible patients; and

  • An overall adverse event profile similar to that of placebo.

"This is an important day for severe, eosinophilic asthma patients who have had limited treatment options for far too long, with many relying on oral steroids to manage their symptoms," Eugene Bleecker, MD, from University of Arizona Health Sciences in Tucson, and lead investigator of one of the trials, said in the release.

"Fasenra has a strong clinical profile, which includes the ability to show lung function improvement after the first dose, the potential to reduce — or even stop — oral steroid use, and the convenience of 8-week dosing. Fasenra also treats a distinct patient phenotype, helping physicians select the right patient in clinical practice with more confidence," Dr Bleecker said.

Last week, the European Medicines Agency Committee for Medicinal Products for Human Use recommended approval of benralizumab for severe eosinophilic asthma, as reported by Medscape Medical News.  

Full prescribing information is available online.  

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