Biogen and AbbVie report that the European Medicines Agency (EMA) has validated the companies' marketing authorization application (MAA) for Zinbryta (daclizumab high-yield process) for the treatment of relapsing forms of multiple sclerosis (MS) in the European Union (EU). 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).

Zinbryta is an investigational drug and a new form of a humanized monoclonal antibody that selectively binds to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is expressed at high levels on T-cells that become abnormally activated in multiple sclerosis (MS). It modulates IL-2 signaling without causing general immune cell depletion and is believed to work by decreasing abnormally-activated T-cells and pro-inflammatory lymphoid tissue inducer cells, and increasing CD56bright natural killer (NK) cells, which are important cells that help regulate the immune system. Biogen and AbbVie are jointly developing Zinbryta.

Source: Biogen