BioCentury
ARTICLE | Clinical News

EMA's PRAC limits use of MS drug Zinbryta due to liver safety concerns

August 4, 2017 7:52 PM UTC

EMA's Pharmacovigilance Risk Assessment Committee (PRAC) announced provisional restrictions on multiple sclerosis drug Zinbryta daclizumab (DAC HYP) that will limit its use while an ongoing liver safety review is completed. Specifically, Zinbryta's use will be limited to patients with highly active relapsing disease who failed to respond to ≥1 disease-modifying therapy and those with rapidly evolving severe relapsing disease who cannot be treated with disease-modifying therapies.

AbbVie Inc. (NYSE:ABBV) and Biogen Inc. (NASDAQ:BIIB) share Zinbryta's rights in the EU. The drug is a humanized IgG1 mAb against IL-2 receptor alpha chain (CD25)...