FDA OKs Abbvie’s and Biogen’s MS DrugBy
The US Food and Drug Administration has approved Biogen’s and AbbVie’s Zinbryta (daclizumab), a new once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS),
Zinbryta is a humanized IgG1 monoclonal antibody that selectively binds to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25). CD25 is expressed at high levels on T-cells that become activated in people with MS.
The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recently granted a positive opinion for Zinbryta. The opinion of the CHMP has been referred to the European Commission for final decision on approval. Zinbryta is also currently under regulatory review in Switzerland, Canada, and Australia.