New Tx for Relapsing MS Moves Closer to Approval as FDA Accepts BLA for Review
Biogen and AbbVie announced that the Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA) for review for Zinbryta (daclizumab high-yield process) in relapsing forms of multiple sclerosis (MS).
The BLA included results from two pivotal trials, DECIDE and SELECT, in which Zinbryta 150mg was administered subcutaneously every four weeks in people with relapsing-remitting MS.
Zinbryta is an investigational humanized monoclonal antibody that selectively binds to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25). Zinbryta modulates IL-2 signaling without causing general immune cell depletion. It is believed to work by decreasing abnormally-activated T-cells and pro-inflammatory lymphoid tissue inducer cells, and increasing CD56bright natural killer (NK) cells.