FDA Approves FASENRA for Severe Eosinophilic Asthma

AstraZeneca and its global biologics research and development arm, MedImmune, announced the US Food and Drug Administration (FDA) has approved FASENRA (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. FASENRA is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

"We're excited to offer FASENRA as a new precision biologic to help improve the lives of severe asthma patients whose disease is driven by eosinophilic inflammation," Pascal Soriot, Chief Executive Officer of AstraZeneca, said. "This is the first approval from our respiratory biologics portfolio and the latest in a series of significant milestones for our company as we deliver on our pipeline-driven transformation."

The FDA approval is based on results from the WINDWARD program, 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 159 mL 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. Adverse events with an incidence greater than or equal to 3% were headache, pyrexia, pharyngitis and hypersensitivity reactions

FASENRA is the only respiratory biologic that provides direct, rapid and near-complete depletion of eosinophils within 24 hours, as observed in a Phase II study. 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-5α receptor on an eosinophil and uniquely attracts natural killer cells to induce apoptosis (programmed cell death). FASENRA 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.

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