FDA Approves Benralizumab for Severe Eosinophilic Asthma

The US Food and Drug Administration (FDA) has approved benralizumab (FASENRA, AstraZenica), a subcutaneous injection for the treatment of severe eosinophilic asthma.

Approval is based on results of WINDWARD program, a combination of 6 phase 3 trials, including the 2 pivotal trials SIROCCO and CALIMA — both randomized, double-blinded, parallel-group placebo-controlled trials designed to evaluate the efficacy and safety of subcutaneous administration of benralizumab (fixed 30mg dose) for up to 56-weeks in exacerbation-prone patients 12 years and older.

Results from the 8-week benralizumab dosing regimen showed:

• Up to 51% reduction in the annual exacerbation rate (AAER) versus placebo
• Significant improvement in lung function as measured by forced expiratory volume in one second (FEV₁) of up to 159 mL versus placebo
• 75% median reduction in daily OCS use and discontinuation of OCS use in 52% of eligible patients
• An overall adverse event profile similar to that of placebo

According to an AstraZenica statement, benralizumab is the only respiratory biologic that provides direct, rapid and near-complete depletion of eosinophils within 24 hours. The treatment binds directly to the IL-5α receptor on an eosinophil and attracts natural killer cells to induce apoptosis (programmed cell death).

The therapy will be available as a subcutaneous injection via a prefilled syringe administered once every 4 weeks for the first 3 doses, and then once every 8 weeks thereafter.

“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,” said Eugene R Bleeker, MD, professor and co-director, genetics, genomics and precision medicine, University of Arizona Health Services, and lead investigator of the pivotal phase 3 SIROCCO study.

Benralizumab will be available in the US within the coming weeks, according to the statement. On November 10, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the marketing authorization of benralizumab. The treatment is also under regalutary review in Japan and several other countries.