The European Commission (EC) approved the first-ever respiratory biologic with an 8-week maintenance dosing schedule.
AstraZeneca, alongside its global biologics research and development channel, MedImmune, released that the EC has given the go-ahead to Fasenra (benralizumab). Fasenra is indicated for use as an add-on maintenance treatment for adults that have severe eosinophilic asthma, which has been inadequately controlled—in spite of high-dose inhaled corticosteroids coupled with long-acting beta-agonists. The drug was granted approval following positive results of the WINDWARD Programme, which consisted of six Phase III trials.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Fasenra is our first respiratory biologic medicine. Today’s decision from the EC follows the recent approval of Fasenra in the US and is another positive step towards our ambition to transform care for severe asthma patients whose disease is driven by eosinophilic inflammation.”
Fasenra works by binding directly to the IL-5α receptor on an eosinophil. Eosinophils are a type of white blood cell that are part of the immune system, however, elevated levels of eosinophils (which is seen in about half of severe asthma patients) can impact airway inflammation and airway hyper-responsiveness. This results in increased asthma severity and symptoms, decreased lung function and increased risk of exacerbations.
Fasenra attracts natural killer cells to induce apoptosis (programmed cell death) on the eosinophil. The drug will be available as a fixed-dose subcutaneous injection via a prefilled syringe. It is administered once every 4 weeks for the first 3 doses, and then once every 8 weeks, thereafter.