The European Medicines Agency (EMA) has validated the Biogen and AbbVie's Marketing Authorisation 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).
“The submission and validation of the MAA are important milestones for Zinbryta and mean this investigational treatment is one step closer to potentially becoming available to MS patients who may benefit from its novel profile,” said Gilmore O’Neill, vice president, multiple sclerosis research and development at Biogen.
The MAA included results from two clinical trials, DECIDE and SELECT, in which Zinbryta 150 mg was administered subcutaneously every four weeks in people with relapsing-remitting MS.
“We are committed to bringing to market medicines that may provide remarkable impact for patients, and the EMA validation of the MAA for Zinbryta is an important step in accomplishing that mission for MS patients,” said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie.
Zinbryta (daclizumab high-yield process) 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). 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, which are important cells that help regulate the immune system.
Biogen and AbbVie are jointly developing Zinbryta.
Through cutting-edge science and medicine, Biogen discovers, develops and delivers to patients worldwide 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. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases.