The US Food and Drug Administration (FDA) has accepted request by Biogen and AbbVie's Biologics License Application (BLA) for marketing approval of Zinbryta (daclizumab high-yield process) for the treatment of multiple sclerosis (MS).
In March 2015 Biogen and AbbVie said that their Marketing Authorisation Application for Zinbryta was recognized by the European Medicines Agency for review in the European Union. The Biological License Application included results from two pivotal trials, DECIDE and SELECT, in which Zinbryta 150 mg was administered subcutaneously every four weeks in people with relapsing-remitting MS. Zinbryta (daclizumab high-yield process) is an investigational treatment and is a new form of a humanised 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 (NK) cells, important cells that help regulate the immune system. Biogen discovers innovative therapies for the treatment of neurodegenerative diseases, hematologic conditions and autoimmune disorders.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories.
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