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news.The European Medicines Agency (EMA) has validated Biogen and AbbVie's marketing authorisation application (MAA) for Zinbryta (daclizumab high-yield process), an investigational drug, to treat relapsing forms of multiple sclerosis (MS) in the European Union (EU).
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The validation of MAA confirms that the submission is complete and signifies the start of the review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
The MAA is based on data from two clinical trials, DECIDE and SELECT, in which Zinbryta 150mg was administered subcutaneously every four weeks in people with relapsing-remitting MS.
Biogen Multiple Sclerosis Research and Development vice-president Gilmore O’Neill said: "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."
Zinbryta 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 multiple sclerosis (MS).
AbbVie Research and Development executive vice-president and chief scientific officer Michael Severino said: "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."
Zinbryta, which is being jointly developed by Biogen and AbbVie, modulates IL-2 signaling without causing general immune cell depletion.