- The European Medicines Agency restricts the use of Biogen’s (NASDAQ:BIIB) MS medication Zinbryta until the completion of a liver safety investigation.
- The EMA will allow the treatment for those with highly active relapsing MS who aren’t responding to other treatments or those with rapidly evolving relapsing MS that aren’t eligible for other treatments.
- Patients with liver injuries should not receive Zinbryta, and those with autoimmune diseases apart from MS should express caution when considering the drug.
- The EU approved Zinbryta last July with warnings and medical monitoring in place to manage known liver damage risks.
- The new safety review launched after a liver failure death of a patient in an ongoing study and four cases of severe liver damage.