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.
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Labeling changes for the multiple sclerosis drug being mandated by European regulators were made to the US label in January.
The Phase IIb-ready, glutamate-modulating candidate shelved by Pfizer after a portfolio review will help Biogen offset the risk posed by its Phase III Alzheimer's candidate aducanumab.
Biogen/AbbVie’s Zinbryta is already being withdrawn worldwide, but EMA now wants the MS drug recalled after mounting reports of serious brain disorders.