Gilead’s Seladelpar Receives Positive CHMP Opinion for Primary Biliary Cholangitis
Gilead Sciences, Inc. (GILD)
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Source: Business Wire
– Recommendation Based on the RESPONSE Study Which Demonstrated ALP Normalization in 25% of Participants at 12 Months and Statistically Significant Reduction of Pruritus Versus Placebo –– If Approved by the European Commission, Seladelpar Would Provide an Important Treatment Option for People Living with the Rare Liver Disease in the EU – FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending seladelpar for the treatment of primary biliary cholangitis (PBC) 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. The final European Commission decision is anticipated in the first quarter of 2025. This follows the accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2024.PBC is a rare,
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