FDA approves Zinbryta to treat multiple sclerosis

June 6, 2016

FDA recently approved daclizumab (Zinbryta, Biogen and AbbVie), a once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS).

FDA recently approved daclizumab (Zinbryta, Biogen and AbbVie), a once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS).

Because of its safety profile, the drug should generally be reserved for patients who have had an inadequate response to 2 or more therapies indicated for the treatment of multiple sclerosis (MS), Biogen said.

“Zinbryta is the first once-monthly, self-administered treatment in MS, and it demonstrated superior efficacy over a widely-used interferon,” said Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen. Clinical data showed Zinbryta significantly reduced relapses and brain lesions for up to 3 years compared to Avonex (interferon beta-1a) intramuscular injection, and has a positive benefit-risk profile with monthly patient monitoring, he added.

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FDA’s approval of Zinbryta is primarily based on results from 2 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 3 years.

In DECIDE and SELECT, Zinbryta significantly reduced the annualized relapse rate (ARR), the primary end point of the studies, by 45% compared to Avonex up to 144 weeks and by 54% compared to placebo at 52 weeks, respectively.

Zinbryta also 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% compared to Avonex at 96 weeks.

In addition, the study showed at up to 144 weeks on Zinbryta, 67% of patients were relapse-free, compared to 51% of the patients taking Avonex.

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The Zinbryta label includes a boxed warning for the risk of hepatic injury, including autoimmune hepatitis, and other immune-mediated disorders. Because of these risks, access to Zinbryta in the United States is restricted to prescribers, pharmacies and patients enrolled in the Zinbryta Risk Evaluation and Mitigation Strategy (REMS) Program, which includes required monthly liver function tests.

The most common adverse reactions that occurred in Zinbryta-treated patients were nasopharyngitis (inflammation of the nose and a part of the throat), upper respiratory tract infection, rash, influenza, dermatitis, oropharyngeal (part of the throat) pain, bronchitis, eczema, and lymphadenopathy (enlargement of the lymph nodes) compared with Avonex; and upper respiratory tract infection, depression, rash, pharyngitis (inflammation of part of the throat), and increased alanine aminotransferase (ALT; a type of liver enzyme) compared with placebo.

The US Zinbryta prescribing information also includes warnings and precautions for hepatic injury, immune-mediated disorders, acute hypersensitivity (inflammatory reaction), infections, depression and suicide.

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