CHMP recommends approval for Zinbryta (daclizumab) intended for the treatment of relapsing forms of multiple sclerosis.- Biogen + Abbvie

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for Zinbryta (daclizumab) intended for the treatment of relapsing forms of multiple sclerosis (RMS), Biogen and AbbVie announced . Zinbryta is a once-monthly, self-administered, subcutaneous investigational treatment for RMS. Zinbryta is also currently under regulatory review in the United States, Switzerland, Canada and Australia.

The CHMP positive opinion is now referred to the European Commission (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 (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. In the DECIDE study, the overall incidence of adverse events was similar in the Zinbryta and Avonex groups. In patients treated with Zinbryta compared to Avonex there was an increased incidence of serious infections (4% versus 2%), serious cutaneous reactions (2% versus lessthan 1%), elevations of liver transaminases greater than five times the upper limit of normal (6% versus 3%), gastrointestinal disorders (31% versus 24%), and depression (8% versus 6%).