What Happened: New York-based Intercept said the FDA handed down a complete response letter related to its NDA for obeticholic acid, which is being evaluated as a treatment option for fibrosis due to NASH.
The decision was expected following the FDA's postponement of an Adcom meeting that was scheduled for June 9.
The company noted that the FDA said the predicted benefit of the drug — based on a surrogate histopathologic endpoint — remains uncertain, and does not sufficiently outweigh the potential risks to support accelerated approval.
The agency recommended that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study and said the long-term outcomes phase of the study should move forward.
"We are disappointed to see the determination the Agency has reached based on an apparently incomplete review, and without having provided medical experts and patients the opportunity to be heard at the anticipated Adcom on the merits of OCA," said Mark Pruzanski, Intercept's president and CEO, said in a statement.
What's Next: Intercept said it plans to meet with the FDA as soon as possible to review the CRL and discuss options for an efficient path forward to approval.
NASH has no treatment option, and Intercept was considered a frontrunner in the NASH drug race.
At last check, Intercept shares were sliding 40.03% to $46.47.