The European Medicines Agency initiated a review of Biogen Inc.'s Zinbryta used to treat adults with relapsing forms of multiple sclerosis.
The review comes after the death from fulminant liver failure of a patient who was treated with Zinbryta in an ongoing observational study, as well as four cases of serious liver injury.
Liver damage was a known risk of the drug when it received EU authorization in July 2016. Several measures were undertaken to prevent or minimize such risk, including the provision of educational materials for healthcare professionals and for patients.
As part of the review, the EMA's Pharmacovigilance Risk Assessment Committee will assess all available data to determine if there are any implications for the use of the product and if there is a need to introduce any new measures to minimize this risk.
Recommendations from the review will be given to the Committee for Medicinal Products for Human Use, which will adopt the agency's opinion. The final stage of the review is the adoption by the European Commission of a legally binding decision applicable in all EU member states.