Pharmacovigilance Risk Assessment Committee Meeting Highlights

At the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) meeting on Jan. 12, 2023, the members reviewed the measures to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. According to the PRAC, the use of lower dose of Olumiant (baricitinib) for patients at higher risk of blood clots, cardiovascular conditions, and cancer is in line with the dosing recommendations for other JAK inhibitors subject to the review are Rinvoq (updacitinib), Cibinqo (abrocitinib), and Jyseleca (filgotinib). 

As for new safety information for healthcare professionals, the PRAC focused on direct healthcare professional communication (DHPC) containing important information on Zolgensma (onasemnogene abeparvovec).

Zolgensma, a gene therapy medicine for the treatment of spinal muscular atrophy, has recently reported fatal cases of acute liver failure in patients treated with it. The DHPC lets healthcare professionals know of the fatal cases of liver failure and the updated recommendations for monitoring liver function, assessing suspected liver injury after infusion, and further advice regarding narrowing the corticosteroid treatment.

The updated DHPC for Zolgensma will be sent to EMA’s committee for advanced therapies and to EMA’s human medicines committee. After being adopted, the DHPC will be disseminated to healthcare professionals by the marketing authorization holders and published on the direct healthcare professional communications’ page and in national registers in EU Member States.

Source: European Medicines Agency