Regulatory Affairs

AstraZeneca gets FDA nod for Fasenra to treat severe eosinophilic asthma

PBR Staff Writer Published 15 November 2017

AstraZeneca, along with its wholly owned subsidiary MedImmune, has secured approval from the US Food and Drug Administration (FDA) for Fasenra (benralizumab) for the treatment of severe eosinophilic asthma.

Fasenra has been approved as an add-on maintenance treatment for patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

The approval was based on data from the Windward program, which is comprised of Phase III exacerbation trials such as Sirocco and Calima and the Phase III oral corticosteroid (OCS)-sparing trial called Zonda.

According to the company, the studies demonstrated up to 51% reduction in the annual asthma exacerbation rate (AAER) compared to placebo and significant improvement in lung function as measured by forced expiratory volume in one second (FEV1) of up to 159mL against placebo.

Fasenra is a monoclonal antibody that deploys natural killer cells to induce direct, rapid and near-complete depletion of eosinophils. It is said to be the only respiratory biologic that can decrease eosinophils within 24 hours

Fasenra adheres directly to the IL-5α receptor on an eosinophil, helping to attract natural killer cells to induce apoptosis (programmed cell death). It is available as a once every eight-week fixed-dose subcutaneous injection through a prefilled syringe.

AstraZeneca CEO Pascal Soriot said: “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.

“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.”