Drug news
Zinbryta (daclizumab) filed with FDA for Multiple Sclerosis-Biogen/AbbVie
The FDA has accepted for review the companies� Biologics License Application (BLA) requesting marketing approval of Zinbryta (daclizumab high-yield process), from Biogen and AbbVie, for relapsing forms of multiple sclerosis (MS). Biogen and AbbVie announced in March 2015 that their Marketing Authorisation Application for Zinbryta was validated by the European Medicines Agency for review in the European Union. The BLA included results from two pivotal trials, DECIDE and SELECT, in which Zinbryta 150 mg was administered subcutaneously every four weeks in people with relapsing-remitting MS.