BRIEF—EU approval for Fasenra follows FDA nod

Fasenra (benralizumab), the first respiratory biologic from Anglo-Swedish pharma major AstraZeneca, has been approved in Europe as an add-on maintenance treatment in adults with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists.

The approval from the European Commission, based on results from the WINDWARD program, comes two months after the nod from the US Food and Drug Administration (FDA), and Fasenra is also under regulatory review in Japan and several other countries.

Fasenra, which was developed by MedImmune, AstraZeneca’s global biologics research and development arm, and is in-licensed from BioWa, a wholly-owned subsidiary of Kyowa Hakko Kirin, is also being evaluated in chronic obstructive pulmonary disease.