13 December 2024 - Recommendation based on the RESPONSE study which demonstrated ALP normalisation in 25% of participants at 12 months and statistically significant reduction of pruritus versus placebo.

Gilead today announced that the CHMP of the EMA adopted a positive opinion recommending seladelpar for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.

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