CHMP Backs Benralizumab for Severe Eosinophilic Asthma

Megan Brooks

Disclosures

November 10, 2017

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of benralizumab (Fasenra, AstraZeneca) as adjunctive maintenance treatment in adults with severe eosinophilic asthma that is poorly controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.

Benralizumab, an antieosinophil humanized monoclonal antibody, targets the interleukin-5 receptor expressed on the surface of eosinophils and basophils. "This leads to apoptosis of eosinophils and basophils through enhanced antibody-dependent cell-mediated cytotoxicity, and therefore, reduces eosinophilic inflammation," the EMA explains in a news release.  

Through its ability to deplete eosinophils in the blood and lung, benralizumab leads to significant reductions in annual exacerbation rates compared with placebo, especially in patients with more than 300 eosinophils per µL of blood before treatment, the EMA says.  The most common side effects are headache (8%) and pharyngitis (3%).

Fasenra will be available as 30-mg solution for injection in prefilled syringes.

The CHMP recommends that benralizumab be prescribed by physicians experienced in the diagnosis and treatment of severe asthma.

Detailed recommendations for the use of benralizumab will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.

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