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Biogen And AbbVie's Once-Monthly ZINBRYTA Gets European Union Approval For Multiple Sclerosis Treatment


Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) disclosed Tuesday that the European Commission (EC) has granted marketing authorization for its ZINBRYTA (daclizumab) for the treatment of adult patients suffering from relapsing forms of multiple sclerosis. According to the companies, ZINBRYTA is a once-monthly, self-administered, subcutaneous injection.

Biogen and AbbVie indicated the EC approval of ZINBRYTA was supported by results from two trials. That included DECIDE, the biggest and longest head-to-head final stage study ever conducted in MS. The company stated that its Phase 2b SELECT, as well as, Phase 3 DECIDE studies were global, randomized, double-blind, controlled studies, which involved about 2,400 people living with RMS. The companies added that some patients in DECIDE were treated for maximum of three years.

AbbVie's chief scientific officer, and EVP for R&D, Michael Severino, commented, "With the approval of ZINBRYTA in the European Union, we are providing a much needed treatment option for people living with MS. This is an important part of AbbVie's ongoing commitment to advancing neuroscience research specifically in the area of MS."

The companies said that in DECIDE and SELECT, its ZINBRYTA reduced patients' annualized relapse rate (ARR) significantly, the primary endpoint of the studies, by 45 percent compared to AVONEX a maximum of 144 weeks and by 54 percent compared to placebo at 52 weeks respectively. The two drug firms added that analyses demonstrated the consistent effect of ZINBRYTA relative to placebo and AVONEX across various subgroups of patients defined by demographic and MS disease characteristics.


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Posted-In: Biotech News FDA General

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