New EU Restrictions On Biogen’s MS Drug Zinbryta Are ‘Damaging’, Analyst Warns
Executive Summary
Biogen is to continue to work closely with the EMA on clear guidance on how to use its MS drug Zinbryta, after the regulators recommended further restrictions on the product’s use because of the risk of liver damage. But an analyst says the restrictions are detrimental for the drug.
You may also be interested in...
EMA Calls For Zinbryta's ‘Immediate’ Suspension After More Reports of Brain Disorders
Biogen/AbbVie’s Zinbryta is already being withdrawn worldwide, but EMA now wants the MS drug recalled after mounting reports of serious brain disorders.
Biogen, AbbVie Withdraw Struggling MS Drug Zinbryta Due To Safety Issues
Antibody was approved in the US with a liver safety warning while EU regulators recently limited the drug's use. Now, EMA has begun an urgent review of reports of inflammatory brain disorders related to Zinbryta.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.