July meeting highlights from EMA Pharmacovigilance Risk Assessment Committee

At its July meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded a safety referral on one medicine, and initiated three new safety referrals. It also discussed two ongoing reviews, extended the scope of an ongoing review, and tested its process and procedures for public hearings in the context of an internal test exercise.

PRAC concludes review of Zydelig and issues updated recommendations for use

The PRAC completed its review of Gilead Sciences’ (Nasdaq: GILD) Zydelig (idelalisib), confirming that the medicine’s benefits outweigh its risks in the treatment of two types of blood cancers, chronic lymphocytic leukemia and follicular lymphoma. The PRAC however confirmed that there is a risk of serious infections with Zydelig, including Pneumocystis jirovecii pneumonia. It updated the recommendations on managing the risk of serious infections that were issued at the beginning of the review.