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FDA Approve Biogen and AbbVie’s Once-Monthly ZINBRYTA

 

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The U.S. Food and Drug Administration (FDA) approved ZINBRYTATM (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 reflects our long-term commitment to bringing therapies to the community that meet the diverse needs of people living with MS,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen.

“ZINBRYTA is the first once-monthly, self-administered treatment in MS, and it demonstrated superior efficacy over a widely used interferon. Clinical data showed ZINBRYTA significantly reduced relapses and brain lesions for up to three years compared to AVONEX® (interferon beta-1a) intramuscular injection, and has a positive benefit-risk profile with monthly patient monitoring.”

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 (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.

“MS affects each person differently, so it is critical that people have additional therapeutic options to address their needs throughout the course of the disease,” said Jeffrey English, M.D., director of clinical research, Multiple Sclerosis Center of Atlanta. “ZINBRYTA provides a meaningful new treatment option that demonstrates efficacy and offers once-monthly dosing.”

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