AbbVie, Biogen receive FDA approval for new MS treatment

SILVER SPRING, Md. — The Food and Drug Administration has approved Biogen and AbbVie’s Zinbryta (daclizumab), the companies announced Tuesday. The drug is a once-daily self-administered injection indicated to treat relapsing forms of multiple sclerosis in patients who have had an inadequate response to two or more MS therapies. 

 

“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,” Biogen EVP and chief medical officer Dr. Alfred Sandrock said. “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 Avonez (interferon beta-1a) intramuscular injection, and has a positive benefit-risk profile with monthly patient monitoring.”

 

Zinbryta’s label contains a boxed warning for the risk of hepatic injury, including autoimmune hepatitis and other immune-mediated disorders. As a result, the drug will only be available to patients, prescribers and pharmacies enrolled in the Zinbryta Risk Evaluation and Mitigation Strategy (REMS) Program, which includes liver function tests monthly.