BioCentury
ARTICLE | Company News

CHMP recommends basket of therapies

November 10, 2017 11:32 PM UTC

EMA's CHMP recommended approval of a host of therapies, including Fasenra benralizumab to treat asthma, Adynovi for hemophilia A and Prevymis letermovir (MK-8228) to prevent cytomegalovirus (CMV) infection.

CHMP backed approval of Fasenra from AstraZeneca plc (LSE:AZN; NYSE:AZN) as an add-on maintenance treatment in adults with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting adrenergic receptor beta 2 (ADRB2) agonists (LABAs). The humanized mAb against IL-5 receptor is also under review in the U.S., with a PDUFA data this quarter, and in Japan. AZ has rights to the candidate from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151)...