Official announcements from regulatory bodies like the FDA, EMA, and others

Gilead's Seladelpar Gets Positive CHMP Opinion for PBC, Shows 62% Response Rate

Dec 13, 2024, 11:39 AM

Gilead Sciences, Inc. has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its drug seladelpar, intended for the treatment of primary biliary cholangitis (PBC) in adults. The recommendation is based on the results from the pivotal placebo-controlled Phase 3 RESPONSE study, which demonstrated that seladelpar achieved a composite biochemical response in 62% of participants at month 12, compared to 20% with placebo. Additionally, 25% of participants on seladelpar normalized their alkaline phosphatase (ALP) levels, a key marker of disease progression in PBC. The drug also significantly reduced pruritus, a common and debilitating symptom of PBC. If approved by the European Commission, seladelpar would provide an important new treatment option for PBC patients in the EU, where the disease affects approximately 15 per 100,000 people, primarily women.