Biogen and AbbVie announced 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).
"We are pleased by the FDA’s acceptance of our BLA for Zinbryta, which we believe has the potential to help people living with MS," said Gilmore O’Neill, vice president, Multiple Sclerosis Research and Development at Biogen.
"We look forward to working with both U.S. and European regulatory authorities to bring this investigational treatment to MS patients as soon as possible."
Biogen and AbbVie announced in March 2015 that their Marketing Authorisation Application for Zinbryta was validated by the European Medicines Agency for review in the European Union.
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.
"This is an important milestone in the development program for Zinbryta and moves us a step closer to potentially bringing a new treatment option to patients with MS," said Michael Severino, M.D., executive vice president, Research and Development and Chief Scientific Officer at AbbVie.
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 (NK) cells, important cells that help regulate the immune system.