Fasenra approved for treatment of severe asthma with eosinophilic phenotype

The FDA approval is based on results from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III oral corticosteroid (OCS)-sparing trial, ZONDA.

Results for the 8-week benralizumab dosing regimen from these trials showed: Up to 51% reduction in the annual asthma exacerbation rate (AAER) versus placebo Significant improvement in lung function as measured by forced expiratory volume in one second (FEV1) of up to 159mL versus placebo. Differences were seen as early as 4 weeks after the first dose, providing an early indication of effectiveness 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.

Fasenra is the only respiratory biologic that provides direct, rapid and near-complete depletion of eosinophils within 24 hours. Eosinophils are a type of white blood cell that are a normal part of the body's immune system. Elevated levels of eosinophils, seen in about half of severe asthma patients, impact airway inflammation and airway hyper-responsiveness, resulting in increased asthma severity and symptoms, decreased lung function and increased risk of exacerbations. Fasenra binds directly to the IL-5? receptor on an eosinophil and uniquely attracts natural killer cells to induce apoptosis (programmed cell death). Fasenra will be available as a once every 8-week fixed-dose subcutaneous injection via a prefilled syringe.

Comment:

On 10 November, 2017, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the marketing authorisation of benralizumab. Benralizumab is also under regulatory review in Japan and several other countries.