Europe's top medicine regulator recommended the immediate suspension and recall of AbbVie Inc. and Biogen Inc.'s multiple sclerosis drug Zinbryta.
The European Medicines Agency's recommendation follows 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis. Of these cases, three were fatal.
The regulator believes the cases are linked to the use of Zinbryta, which is intended to treat multiple sclerosis, a disease that affects the brain and the spinal cord.
The regulator had previously asked that the use of the drug be restricted only to patients who had failed two other multiple sclerosis treatments.
The European Commission will need to sign off on the EMA's recommendation before it becomes legally binding.
Biogen and AbbVie have already withdrawn the global market authorizations for the drug due to safety issues.
Zinbryta generated $53 million in 2017 revenues for Biogen — the least in its multiple sclerosis drug portfolio that also includes Tecfidera, which had $4.2 billion in sales during that same period.
