Policy & Regulation
European Commission grants approval to AstraZeneca for Fasenra
12 January 2018 -

The European Commission has granted approval to United Kingdom-based AstraZeneca for its Fasenra (benralizumab) as an add-on maintenance treatment for patients with severe eosinophilic asthma.

It was reported yesterday that the approval is for the treatment of adult patients in whom the condition is inadequately controlled even after being subjected to high-dose inhaled corticosteroids and long-acting beta-agonists. It was granted based on the findings of the WINDWARD study, comprised of six phase 3 trials including the pivotal SIROCCO and CALIMA exacerbation trials, and the OCS-sparing trial, ZONDA.

The product is a monoclonal antibody that uses natural killer cells to induce direct, fast and almost-complete depletion of eosinophils. Fasenra, which was developed by AstraZeneca with its global biologics research and development arm MedImmune, was approved in the US in November 2017 for the treatment of severe eosinophilic asthma.



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