FDA Approves Once-Monthly ZINBRYTA™ (daclizumab) of Biogen and AbbVie for Multiple Sclerosis


May 27, 2016

Biogen and AbbVie have announced that The U.S. Food and Drug Administration (FDA) approved ZINBRYTA™ (daclizumab), a new once-monthly, subcutaneous, self-administered treatment for relapsing forms of multiple sclerosis (RMS).  The companies also added that because of its safety profile, ZINBRYTA should generally be used for patients who have had an inadequate response to two or more therapies indicated for treating multiple sclerosis (MS).

Alfred Sandrock, M.D., Ph.D., 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. 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.”

“MS patients are in need of therapeutic choices to help manage their disease and ZINBRYTA is an important new option for patients. AbbVie is committed to making a remarkable impact on the lives of patients, including in MS where there are particular unmet needs,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.


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