Biogen, AbbVie Advance MS Drug
Biogen and AbbVie report that the US Food and Drug Administration (FDA) has accepted for review the companies' biologics license application (BLA) requesting marketing approval of Zinbryta (daclizumab high-yield process) for relapsing forms of multiple sclerosis (MS).
Biogen and AbbVie announced in March 2015 that their marketing authorization application for Zinbryta was validated by the European Medicines Agency for review in the European Union.
Zinbryta (daclizumab high-yield process) is an investigational treatment and is 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 MS. Zinbryta modulates IL-2 signaling without causing general immune cell depletion. Zinbryta is believed to work by decreasing abnormally-activated T-cells and pro-inflammatory lymphoid tissue inducer cells, and increasing CD56bright natural killer cells, important cells that help regulate the immune system.
Biogen and AbbVie are jointly developing Zinbryta.