In a rare move, pharmaceutical manufacturers voluntarily recalled their drug to treat multiple sclerosis (MS) after reports of serious brain inflammation in patients.
AbbVie and Biogen voluntarily recalled daclizumab (Zinbryta) worldwide for relapsing MS because “the companies believe that characterizing the complex and evolving benefit/risk profile of Zinbryta will not be possible going forward, given the limited number of patients being treated,” the two companies said in a statement.
The European Medicines Agency (EMA) called for an urgent review of the drug after 7 patients in Germany and 1 patient in Spain experienced encephalitis and/or meningoencephalitis (brain inflammation).
More than 8,000 patients around the world have received Zinbryta, according to the EMA. It is sold in the European Union, the US, Switzerland, Canada, and Australia.
“Biogen believes the voluntary worldwide withdrawal of Zinbryta….is in the best interest of patients,” said Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen, in the statement. “Biogen and AbbVie continue to prioritize patient safety and the care of multiple sclerosis patients worldwide.”
Patients who are currently being treated with Zinbryta should contact their healthcare provider if they have any questions or concerns, the two companies said.
While daclizumab was approved by FDA in 2016 to treat MS, the agency warned that the drug could cause "serious or life-threatening liver damage" and "serious immune system disorders,” CNN reported.