FDA approves Zinbryta (daclizumab) to treat relapsing multiple sclerosis- Biogen + AbbVie

The FDA approved Zinbryta (daclizumab), a new once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS), Biogen and AbbVie announced . Because of its safety profile, the use of Zinbryta should generally be reserved for patients who have had an inadequate response to two or more therapies indicated for the treatment of multiple sclerosis (MS). The FDA approval of Zinbryta is primarily based on results from two clinical trials, including DECIDE, the largest and longest head-to-head Phase III clinical trial 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 the 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. Results from DECIDE showed that Zinbryta demonstrated superior efficacy across multiple measures of MS disease activity (relapses and MRI) compared to Avonex, including a significant reduction in the mean number of new or newly enlarging T2-hyperintense lesions by 54 percent compared to Avonex at 96 weeks (p<0.0001). Additionally, the study showed at up to 144 weeks on Zinbryta, 67 percent of patients were relapse free compared to 51 percent of the patients taking Avonex.

Comment: Zinbryta has serious safety risks, including liver injury and immune conditions. Because of the risks, Zinbryta has a boxed warning and is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy.

Comment: Zinbryta was CHMP recommended in pril 2016.