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AUGUST 23, 2024

FDA Approves Seladelpar for Primary Biliary Cholangitis


Originally published by our sister publication Gastroenterology & Endoscopy News

By GEN Staff

The FDA has granted accelerated approval to seladelpar (Livdelzi, Gilead) in combination with ursodeoxycholic acid for adults with primary biliary cholangitis.

The drug, a peroxisome proliferator−activated receptor delta agonist, is approved as a monotherapy for patients who have had an inadequate response to or cannot tolerate UDCA. It is not recommended in patients with decompensated