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Intercept to Discontinue OCA NASH Development Following Second CRL
Intercept Pharmaceuticals announced it received a CRL from FDA regarding the obeticholic acid (OCA) NDA for the treatment of pre-cirrhotic liver fibrosis due to NASH. According to the press release, FDA indicated in the CRL that any resubmission of an NDA for OCA in NASH would require, at minimum, successful completion of the long-term outcomes phase of the REGENERATE study (view CT.gov record). As a result of the CRL, Intercept has decided to discontinue all NASH-related investment and restructure the company’s operations to strengthen its focus on rare and serious liver diseases. Below, FENIX provides brief thoughts on the CRL and Intercept’s decision.