AbbVie, Biogen Get EMA Advisory Committee Nod for MS DrugBy
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for Zinbryta (daclizumab) intended for the treatment of relapsing forms of multiple sclerosis (RMS) by Biogen and AbbVie. Zinbryta is a once-monthly, self-administered, subcutaneous investigational treatment for RMS. Zinbryta is also currently under regulatory review in the United States, Switzerland, Canada and Australia.
The CHMP positive opinion is now referred to the European Commission (EC), which grants marketing authorizations for centrally authorized medicines in the European Union. A decision from the EC is expected within the coming months.
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 activated in people with MS. Zinbryta modulates IL-2 signaling without general immune cell depletion. The drug is being jointly developed by AbbVie and Biogen.