EMA Validates Marketing Authorisation Application for Zinbryta (Daclizumab High-Yield Process) for Treatment of MS

Biogen and AbbVie have announced that the European Medicines Agency (EMA) has validated the companies’ Marketing Authorisation Application (MAA) for Zinbryta, (daclizumab high-yield process) for the treatment of relapsing forms of multiple sclerosis (MS) in the European Union. Validation confirms that the submission is complete and signifies the initiation of the review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

“The submission and validation of the MAA are important milestones for Zinbryta and mean this investigational treatment is one step closer to potentially becoming available to MS patients who may benefit from its novel profile,” said Gilmore O’Neill, Vice President, Multiple Sclerosis Research and Development at Biogen.

The MAA included results from two clinical trials, DECIDE and SELECT, in which Zinbryta 150 mg was administered subcutaneously every  weeks in people with relapsing-remitting MS.

“We are committed to bringing to market medicines that may provide remarkable impact for patients, and the EMA validation of the MAA for Zinbryta is an important step in accomplishing that mission for MS patients,” said Michael Severino, Executive Vice President of R&D and Chief Scientific Officer, AbbVie.