FDA Approves Biologic Drug for Eosinophilic Asthma

The FDA recently approved benralizumab (Fasenra) as an add-on therapy for patients aged 12 years and older with severe eosinophilic asthma, according to a press release.

Benralizumab is a monoclonal antibody that causes natural killer immune cells to deplete eosinophils within 24 hours. Eosinophils are involved in approximately 50% of asthma cases and result in exacerbations and impaired lung functions, according to AstraZeneca.

“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 Pascal Soriot, chief executive officer of AstraZeneca. “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 was based on positive findings from the WINDWARD program, which included several phase 3 clinical trials.

The investigators found that 8 weeks of benralizumab therapy reduced the annual asthma exacerbation rate 51% compared with placebo, according to the study.

The investigators also found observed improvements in lung function as early as 4 weeks after benralizumab initiation compared with placebo. These findings demonstrate that the biologic may provide significant benefits early on, according to the release.

Additionally, benralizumab-treated patients were able to reduce oral corticosteroid use by 75%, with 52% of patients completely discontinuing steroid use. AstraZeneca reports that uncontrolled asthma can result in dependence on oral corticosteroids, which can cause adverse effects, including weight gain, diabetes, osteoporosis, glaucoma, anxiety, depression, heart disease, and immunosuppression.

Overall, adverse events between both cohorts were similar, according to the release.

AstraZeneca reports that Fasenra is the only biologic that directly and rapidly eliminates eosinophils within 24 hours of treatment.

Benralizumab is indicted for administration once every 8-weeks in a fixed-dose subcutaneous injection via pre-filled syringe, according to the release.

“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. 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,” said lead investigator of the SIROCCO study Eugene Bleecker, MD. “Fasenra also treats a distinct patient phenotype, helping physicians select the right patient in clinical practice with more confidence.”