EMA recommends Biogen’s MS treatment Zinbryta

pharmafile | May 3, 2016 | News story | Research and Development, Sales and Marketing |  Biogen, CHMP, EMA, daclizumab, zinbryta 

The Committee for Medicinal Products for Human Use (CMHP) has recommended the granting of a marketing authorisation for Zinbryta (daclizumab) for the treatment of relapsing forms of multiple sclerosis.

Developed by Biogen, Zinbryta is a humanised IgG1 monoclonal antibody that demonstrated statistical significance in the reduction of annualised relapse rate of multiple sclerosis in the DECIDE Phase III trial. In the same trial, a reduction in the number of new or newly enlarging T2-hyperintense lesions was also observed.

The full indication from the European Medicines Agency is: “Zinbryta is indicated in adult patients for the treatment of relapsing forms of multiple sclerosis.” The marketing authorisation from the European Commission is expected to be ratified following the EMA’s recommendation.

Sean Murray