AstraZeneca upbeat on FDA approval for asthma treatment Fasenra

AstraZeneca and its global biologics research and development arm, MedImmune, announced on Wednesday that the US Food and Drug Administration 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.

The FTSE 100 company said the FDA approval was based on results from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III oral corticosteroid-sparing trial, ZONDA.

“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,” said AstraZeneca CEO Pascal Soriot.

“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 company said results for the eight-week benralizumab dosing regimen from those trials showed an up-to-51% reduction in the annual asthma exacerbation rate versus placebo, and a “significant improvement” in lung function as measured by forced expiratory volume in one second of up to 159mL versus placebo.

Differences were seen as early as four weeks after the first dose, providing an early indication of effectiveness, the board reported.

It also showed a 75% median reduction in daily oral corticosteroid use and discontinuation of oral corticosteroid use in 52% of eligible patients, and an overall adverse event profile similar to that of placebo.

“This is an important day for severe, eosinophilic asthma patients who have had limited treatment options for far too long, with many relying on oral steroids to manage their symptoms,” said Eugene Bleecker, professor and co-director of genetics, genomics and precision medicine at the University of Arizona Health Sciences, and the lead investigator of the pivotal Phase III SIROCCO study.

“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.”

AstraZeneca said 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, it explained.

Fasenra reportedly binds directly to the IL-5α receptor on an eosinophil, and uniquely attracts natural killer cells to induce apoptosis - programmed cell death.

AstraZeneca said Fasenra will be available as a once every eight-week fixed-dose subcutaneous injection via a prefilled syringe.