Posted by Michael Wonder on 11 Jan 2018
AstraZeneca receives EU approval of Fasenra for severe eosinophilic asthma
10 January 2018 - Fasenra is the first-ever approved respiratory biologic medicine with an 8-week maintenance dosing schedule.
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the European Commission 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.
