European Commission approves Zinbryta (subcutaneous daclizumab) to treat relapsing multiple sclerosis.- Biogen + AbbVie

The European Commission (EC) has granted marketing authorization for Zinbryta (daclizumab) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), Biogen and AbbVie announced. Zinbryta is a once-monthly, self-administered, subcutaneous injection. The EC approval of Zinbryta is supported by results from two studies, including DECIDE, the largest and longest head-to-head Phase III study ever conducted in MS.

The Phase IIb SELECT and Phase III DECIDE studies were global, randomized, double-blind, controlled studies that involved approximately 2,400 people living with RMS. Some patients in DECIDE were treated for up to three years. In DECIDE and SELECT, Zinbryta significantly reduced patients� annualized relapse rate (ARR), the primary endpoint of the studies, by 45 percent compared to Avonex up to 144 weeks and by 54 percent compared to placebo at 52 weeks (both p<0.0001), respectively. analyses of these studies demonstrated the consistent effect of zinbryta relative to placebo and avonex across various subgroups of patients defined by demographic and ms disease characteristics.>