The FDA has approved AstraZeneca's biologic drug benralizumab (Fasenra) for the add-on maintenance treatment of patients age 12 years and over with severe asthma with an eosinophilic phenotype, the late Tuesday.
Approval was based on pivotal trials showing up to a 51% reduction in the annual asthma exacerbation rate versus placebo in patients with uncontrolled, severe asthma and high levels of eosinophilia. The drug also showed an overall adverse event profile similar to that of placebo in the trials, and users had median 75% reductions in daily oral corticosteroid use.
Benralizumab becomes the first approved monoclonal antibody with an 8-week maintenance dosing schedule, following three initial doses given every 4 weeks.
It's the first approved drug that targets the interleukin-5α receptor. The two other IL-5 biologics approved by the FDA for severe, uncontrolled asthma -- GlaxoSmithKline's mepolizumab (Nucala) and Teva's reslizumab (Cinqair) -- both target the circulating IL-5 protein.
Trial results showed that benralizumab injections given once every 4 or 8 weeks decreased eosinophil counts, reduced asthma exacerbations, and improved lung function in patients with uncontrolled asthma with persistent eosinophilia.
In a press statement, AstraZeneca announced that benralizumab will be available for patients in the United States "within the coming weeks."