PRAC meeting highlights 9-12 January 2023

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring safety issues for human medicines.

The current PRAC highlights from the January 2023 meeting describes recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors, and provides information on fatal cases of acute liver failure recently reported in patients treated with Zolgensma (onasemnogene abeparvovec), a gene therapy medicine for the treatment of spinal muscular atrophy.