Biogen & Abbvie’s Zinbryta treatment for MS granted marketing authorisation by EC

Biogen and AbbVie have announced that the European Commission has given marketing authorisation for Zinbryta, to be used as treatment of adult patients with relapsing forms of multiple sclerosis.

“With the approval of Zinbryta in the European Union, we are providing a much needed treatment option for people living with MS,” added Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “This is an important part of AbbVie’s ongoing commitment to advancing neuroscience research specifically in the area of MS.”

The European Comission’s approval of Zinbryta was supported by results from two studies, including DECIDE, the largest and longest head-to-head Phase III study ever conducted in Multiple Sclerosis. The Phase IIb SELECT and Phase III DECIDE studies involved approximately 2,400 people living with RMS. In both studies, Zinbryta had significantly reduced patients’ annualised relapse rate (ARR) (which was the primary endpoint of the studies) by 45 percent compared to Avonex (interferon beta-1a) up to 144 weeks and by 54 percent compared to placebo at 52 weeks, respectively. Analysis of these studies demonstrated the consistent effect of Zinbryta when compared to the placebo and Avonex across various subgroups of patients defined by demographic and MS disease characteristics.

Commenting on the study results and today’s news, Professor Gavin Giovannoni, Chair of Neurology at the Blizard Institute, Barts and The London School of Medicine and Dentistry, commented: “Clinical data showed Zinbryta significantly reduced relapses, 24-week confirmed disability progression and new brain lesions for up to three years compared to Avonex intramuscular injection, providing a valuable new option for people with RMS. Zinbryta has an immunomodulatory mechanism of action (MOA) that regulates inflammation without broadly depleting the immune system, and immune cell effects are reversible within six months. This offers an alternative approach to treating multiple sclerosis (MS) and is an important consideration when deciding how to sequence therapies throughout the course of a patient’s disease.”

Zinbryta’s MOA is believed to block the activation of autoreactive T-cells, a major contributor to inflammation in the nervous system of patients with MS. This therapy leads to an increase in immunoregulatory CD56bright natural killer (NK) cells, which have shown to selectively decrease activated T-cells that contribute to the nerve injury triggered by MS. These immunomodulatory effects of Zinbryta are believed to reduce central nervous system pathology in MS and thereby reduce the occurrence of relapse and disability progression.


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