Drug makers Biogen and AbbVie have pulled off the market and stopped all clinical trials on their multiple sclerosis drug daclizumab (sold under the brand name Zinbryta), after receiving eight reports of serious brain inflammation among patients in Europe. The measure was taken on the same day the European Medicines Agency announced an “urgent review” of the drug.
Seven patients in Germany and one in Spain who were treated with the drug developed encephalitis and/or meningoencephalitis, both of which are brain inflammations.
“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,” the companies said in a statement. “Therefore, Biogen and AbbVie believe it is in the best interest of patients to voluntarily withdraw worldwide marketing authorizations for Zinbryta.”
The drug was approved for use in the European Union, the United States, Switzerland, Canada, and Australia. More than 8,000 people have been treated with Zinbryta, most of whom are in Germany.
The U.S. Food and Drug Administration (FDA) approved the monthly injection in May 2016 for patients with relapsing-remitting multiple sclerosis. At that time, the FDA warned that the drug could cause serious or life-threatening liver damage and serious immune system disorders. The agency also restricted the medication for patients who had tried at least two other disease-modifying treatments and were unable to be on any other multiple sclerosis drugs.
European drug regulators are advising doctors not to start any new patients on Zinbryta, and to immediately contact patients currently taking the medication to look for signs or symptoms of brain inflammation, such as fever, seizures, changes in behavior, confusion, and disorientation.
The National Institutes of Health recommends immediate and aggressive medical intervention for any form of encephalitis.