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Intercept Turns To RWE To Confirm Ocaliva’s Benefit In PBC After NASH Complete Response Letter

 
• By Sue Sutter

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.

irrigation pivot
Intercept's plan for pivoting to near-term profitability includes discontinuing OCA's development in NASH. • Source: Shutterstock

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.

Following receipt of a second US Food and Drug Administration complete response letter for obeticholic acid (OCA), a farnesoid X receptor agonist, in NASH, the company on 22 June announced it was discontinuing all development activity and investment in this indication and refocusing on

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