Daclizumab pulled from market worldwide
Reports of inflammatory brain disorders in Europe lead to voluntary withdrawal
Biogen and AbbVie are voluntarily pulling MS treatment daclizumab (Zinbryta) from the market worldwide after several cases of serious inflammatory brain disorders in Germany and Spain were linked to the biologic, including cases of encephalitis and meningoencephalitis. The manufacturers announced the withdrawal on Friday, March 2, the same day the European Medicines Agency (EMA) launched an urgent safety review of daclizumab and declared that it would stop ongoing clinical trials in the European Union.
In a statement, the manufacturers said they believe it would not be possible to characterize the risk-benefit profile of daclizumab because of the limited number of patients who use it. Approximately 8,000 patients have received daclizumab worldwide.
Daclizumab was approved by FDA in May 2016 for the treatment of relapsing forms of MS, with the caveat that it be used only in patients who have had an inadequate response to two or more MS drugs. FDA approval included a black box warning about potential liver damage and immune conditions from daclizumab, and the biologic was only available in the US through a restricted distribution program under a Risk Evaluation and Mitigation Strategy. Thus far FDA has not issued a statement about the withdrawal, but EMA has recommended that physicians review patients who take daclizumab and start alternative therapies as soon as possible, and refrain from starting treatment with daclizumab in new patients.