Intercept Pharmaceuticals, Inc. is looking to real-world evidence, and potentially a Phase III trial with a fixed-dose combination, to help secure Ocaliva’s (obeticholic acid) current indication in primary biliary cholangitis now that the company has decided to discontinue development in nonalcoholic steatohepatitis (NASH) fibrosis.
Intercept Turns To RWE To Confirm Ocaliva’s Benefit In PBC After NASH Complete Response Letter
Using real-world evidence and potentially a Phase III trial with a fixed-dose combination, Intercept is refocusing on fulfilling postmarketing requirements for obeticholic acid’s current indication in primary biliary cholangitis after ending development of the drug in nonalcoholic steatohepatitis due to FDA’s second rejection of accelerated approval.
