AbbVie, Biogen: FDA Approves Once-Monthly ZINBRYTA For Multiple Sclerosis

(RTTNews) - AbbVie (ABBV), a research-based biopharmaceutical company, and Biogen (BIIB) late Friday announced that the U.S. Food and Drug Administration or FDA approved ZINBRYTA (daclizumab), a new once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis or RMS.

Biogen and AbbVie are co-promoting ZINBRYTA in the United States.

The FDA approval of ZINBRYTA is primarily based on results from two clinical trials, including DECIDE, the largest and longest head-to-head Phase 3 clinical trial ever conducted in MS.

The Phase 2b SELECT and Phase 3 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, 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, respectively.

Alfred Sandrock, executive vice president and chief medical officer at Biogen, said, "The FDA approval of ZINBRYTA reflects our long-term commitment to bringing therapies to the community that meet the diverse needs of people living with MS. ZINBRYTA is the first once-monthly, self-administered treatment in MS, and it demonstrated superior efficacy over a widely used interferon."

In the U.S. only, 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, the companies noted.