Officials with the FDA have approved benralizumab (Fasenra, AstraZeneca) for the add-on maintenance treatment of patients with severe eosinophilic asthma aged 12 years and older, according to a company press release.
The approval is based on data from clinical trials that evaluated 8-week benralizumab dosing regimens in patients with asthma. According to the press release, results from the data showed:
• Up to 51% reduction in the annual exacerbation rate compared to a placebo.
• Significant improvement in lung function as measured by forced expiratory volume in 1 second of up to 159mL versus placebo. Differences were seen asearly as 4 weeks after the first dose, providing an early indication of effectiveness.
• 75% median reduction in daily oral corticosteroid use (OCS) and discontinuation of OCS use in 52% of eligible patients.
With this approval, benralizumab is the only respiratory biologic that provides direct, rapid, and near-complete depletion of eosinophils within 24 hours. Elevated levels of eosinophils are seen in about half of patients with severe asthma, causing increased asthma severity and symptoms, decreased lung function, and increased risk of exacerbations. Benralizumab works by binding directly to the IL-5α receptor on an eosinophil and attracting natural killer cells to induce programmed cell death.
Benralizumab will be available as a once every 8-week fixed-dose subcutaneous injection via a prefilled syringe.