WESTON (dpa-AFX) - Biogen Inc. (BIIB) and AbbVie Inc. (ABBV) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a positive opinion recommending the granting of a marketing authorization for Zinbryta or daclizumab, intended for the treatment of relapsing forms of multiple sclerosis or RMS.
Zinbryta is a once-monthly, self-administered, subcutaneous investigational treatment for RMS. Zinbryta is also currently under regulatory review in the U.S." Switzerland, Canada and Australia.
The CHMP positive opinion is now referred to the European Commission or EC, which grants marketing authorizations for centrally authorized medicines in the European Union. A decision from the EC is expected within the coming months.
According to the CHMP opinion, the benefits of Zinbryta are its ability to reduce the annualized relapse rate or ARR, as well as the risk of 24-week confirmed disability progression.
The opinion is based on results from two clinical trials, DECIDE and SELECT, in which Zinbryta 150 mg, administered subcutaneously every four weeks improved results on key measures of MS disease activity in patients with RMS compared to Avonex 30 mcg intramuscular injection administered weekly and placebo, respectively.
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