EMA validates Biogen and AbbVie's Zinbryta MAA for multiple sclerosis

The European Medicines Agency has validated the Marketing Authorization Application for US biotech firms Biogen (Nasdaq: BIIB) and AbbVie (NYSE: ABBV) for Zinbryta (daclizumab high-yield process) for the treatment of relapsing forms of multiple sclerosis (MS).

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 andvalidation 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 R&D at Biogen.