Biogen and AbbVie have withdrawn their multiple sclerosis drug, Zinbryta, worldwide following dangerous brain inflammation in patients in Europe.
The European Medicines Agency has started an urgent review of Zinbryta (daclizumab) following seven cases of serious inflammatory brain disorders in Germany, including encephalitis and meningoencephalitis, and one case in Spain.
Zinbryta, a self-administered, under-the-skin injection designed to treat adults with relapsing forms of multiple sclerosis was approved by the U.S. FDA in 2016.
According to a company statement from Biogen and AbbVie, “Given the nature and complexity of adverse events being reported, characterizing the evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated."
Read the EMA report