FDA OKs Monthly Multiple Sclerosis Drug: Zinbryta

There’s now a once-a-month injection for treating relapsing multiple sclerosis.

The drug is called Zinbryta (daclizumab) and it was just approved by the Food and Drug Administration.  Zinbryta is self-administered subcutaneously, which means using Printneedles that are shorter than the ones that are used for drugs, such as Avonex, which are administered into the muscle.

Clinical data, reported by Zinbryta’s manufacturer, Biogen, shows Zinbryta significantly reduced relapses and brain lesions for up to three years compared to Avonx. (interferon beta-1a).

Zinbryta research

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 by 45 percent compared to AVONEX and by 54 percent compared to a placebo.

Zinbryta risks

There are risks involved with Zinbryta.  Because of that, the manufacturer’s news release says the drug “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 Zinbryta label includes a warning for the risk of hepatic injury, including autoimmune hepatitis, and other immune-mediated disorders. Because of these risks patients using the drug will be closely monitored and will undergo monthly liver function tests.

Zinbryta is being marketed in the U.S. by Biogen and AbbVie.

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