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Wednesday, May 4, 2016

Zinbryta (daclizumab HYP) is favored for approval in Europe

                                                                  

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May 4, 2016


he Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently recommended marketing authorization to Zinbryta (daclizumab) for the treatment of patients with relapsing multiple sclerosis (RMS).
Zinbryta (daclizumab HYP) is a humanized monoclonal antibody that is injected every four weeks, and being developed by Biogen and AbbVie. It binds to the receptor subunit CD25 of interleukin-2 (IL-2), which is highly expressed in immune T-cells. These immune cells are overly expressed in MS, and Zinbryta is thought to deplete the activated T-cells and increase other cells that regulate the immune response (NK cells). The compound is currently under regulatory review in the United States, Canada, Australia, and Switzerland.
“For people with relapsing forms of MS (RMS) and active disease, ZINBRYTA has the potential to offer robust efficacy, a manageable safety profile through patient monitoring, and once-monthly subcutaneous dosing,” said Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen, in a recent press release. “ZINBRYTA may offer another option for people with multiple sclerosis (MS) with its targeted mechanism of action (MOA) which did not cause broad and prolonged immune cell depletion.”
The European Commission (EC) will now review the CHMP positive opinion, and make its decision in the coming months.



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