Published on 23 Jun 2023 on Zacks via Yahoo Finance
Intercept Pharmaceuticals, Inc. ICPT announced that the FDA issued a complete response letter (CRL) in response to the company’s new drug application (NDA) seeking approval for obeticholic acid (OCA) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH).
The FDA indicated in the CRL that the NDA cannot be approved in its present form following a review.
The NDA resubmission will require successful completion of the long-term outcomes phase of the REGENERATE study per the content of the CRL.