AstraZeneca and its global biologics research and development arm, MedImmune, announced that the European Commission (EC) has approved Fasenra (benralizumab) as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists.
The approval is based on the results from the WINDWARD programme, including the pivotal Phase III exacerbation trials,SIROCCO and CALIMA, and the Phase III OCS-sparing trial, ZONDA.
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.”
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. Fasenra binds directly to the IL-5α receptor on an eosinophil and attracts natural killer cells to induce apoptosis (programmed cell death). Fasenra will be available as a fixed-dose subcutaneous injection via a prefilled syringe administered once every 4 weeks for the first 3 doses, and then once every 8 weeks thereafter.
Tim Harrison, Professor of Asthma and Respiratory Medicine, University of Nottingham, UK, and investigator in the WINDWARD trial programme, said: “Many patients with severe eosinophilic asthma experience debilitating symptoms and face increased risk of emergency room visits, hospitalisations and death, despite current treatments. I look forward to being able to offer Fasenra as a new anti-eosinophilic monoclonal antibody which has demonstrated efficacy versus placebo in pivotal clinical trials and has the convenience of an 8-week maintenance dosing regimen.”
In November 2017, the US Food and Drug Administration (FDA) approved Fasenra for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Fasenra is also under regulatory review in Japan and several other countries, with expected regulatory decisions in H1 2018.