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

Executive Summary

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.

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