Intercept pivots away from NASH following second FDA rejection for obeticholic acid
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Key takeaways:
- FDA rejected Intercept’s obeticholic acid for treatment of pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis.
- Intercept abandons NASH-related investments to renew focus on “rare and serious liver diseases.
The FDA issued a complete response letter to Intercept indicating it cannot approve the company’s new drug application for obeticholic acid as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis.
Following an unfavorable vote before the FDA’s Gastrointestinal Drug Advisory Committee in May, the agency’s rejection of obeticholic acid (Ocaliva, Intercept Pharmaceuticals) was not unexpected. In its letter, the FDA emphasized that any resubmission of obeticholic acid (OCA) for NASH would require at least successful completion of long-term patient outcomes data from the REGENERATE study.
However, already saddled with two FDA rejections for NASH after OCA’s initial rebuff in 2020, Intercept has opted instead to discontinue its NASH-related investments, reorganize its operations “to strengthen its focus on rare and serious liver diseases” and pivot toward profitability in 2024.
“While this is clearly not the outcome that we have worked toward, I’m proud of the impact that Intercept has made to move the science of NASH forward and bring the field closer to a treatment option,” Jerry Durso, president and CEO of Intercept, said in an Intercept press release. “Intercept thanks the scientists, clinicians and patients whose contributions to the clinical development of OCA in NASH have significantly advanced the understanding of this deadly disease.”
He added: “We believe that taking decisive action to reshape Intercept will improve our long-term ability to grow our business, innovate for patients and create value for shareholders. We remain committed to the liver community and will continue to advance our leadership in rare and serious liver diseases where Intercept has deep expertise and a recognized dedication to therapeutic innovation.”
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