AstraZeneca’s Fasenra cleared in Europe (EU)

The European Commission (EC) has approved AstraZeneca’s Fasenra as an add-on maintenance treatment in certain adult patients with severe eosinophilic asthma.

AstraZeneca and its global biologics research and development arm, MedImmune, on Wednesday said in the announcement that Fasenra (benralizumab) will be an addition treatment for the patients with 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, AZ said in its announcement.

Sean Bohen, 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.”

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.”