EMA validates Marketing Authorisation Application for Zinbryta for treatment of MS
Posted: 31 March 2015 |
Biogen and AbbVie have announced that the EMA has validated the companies’ MAA for Zinbryta for the treatment of relapsing forms of MS in the EU…
Biogen and AbbVie have announced that the European Medicines Agency (EMA) has validated the companies’ Marketing Authorisation Application (MAA) for Zinbryta™ 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).
Zinbryta is an investigational drug and a new form of a humanized monoclonal antibody
Zinbryta is a 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 signalling 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 cells, which are important cells that help regulate the immune system.
“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.
For more information about Biogen, please visit www.biogen.com.
For more information about AbbVie, please visit www.abbvie.com.
