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On June 29, Intercept Pharmaceuticals announced that it had received a full response letter (CRL) from the FDA regarding the application of its FXR agonist Obecholic Acid (OCA) for fibrosis caused by non-alcoholic fatty hepatitis (NASH).
FDA said in CRL that based on data reviewed so far, the expected benefits of the drug based on alternative tissue pathology trial endpoints remain uncertain and that the therapeutic benefits do not outweigh the potential risks, and therefore does not support accelerated approval of OCA for the treatment of patients with NASH-causing liver fibrosis. Mark Pruzanski, president and chief executive officer of
Intercept, said of the results: "During the review process, the FDA never conveyed a message of accelerated approval of the OCA, and we strongly believe that all data submitted to date meets FDA requirements and clearly supports the positive return risks of the OCA."
we are very sorry about this CRL.
FDA has gradually increased the complexity of histological endpoints, creating a very high threshold for passing, a requirement that OCA has so far met in only one key Phase 3 study.
we plan to meet with the FDA as soon as possible to discuss how to approve the proposal in the future with crL information.
" Intercept has been a leader in the race to seize the first NASH drug to go on sale and is currently the only company to have access to positive late-stage trial data.
As a powerful, specific version of Theniol X-receiving (FXR) astigtor, OCA had previously achieved positive results in a Phase 3 clinical trial called REGENERATE, which showed that one in four patients receiving high doses of OCA had significantly improved symptoms of liver tissue fibrosis and that the condition had not worsened.
FDA recommends that Intercept submit additional interim analytical validity and safety data from the ongoing REGENRATE study to support OCA's potentially accelerated approval, noting that the long-term results of the study should continue.
OCA has previously been approved for another rare liver disease (PBC), there is plenty of room for NASH.
estimates that NASH affects millions of people in the United States alone.
JMP Securities, an investment bank, had previously estimated that Sales of Intercept drugs could peak at billions of dollars.
shares fell nearly 40 per cent to $47.25 on Monday after the news came as a result of the short-selling news.
other drugmakers that also developed NASH fell, with Madrigal down about 6 per cent and Viking, Akero and GenFit down about 1 per cent each.
Stifel analyst Derek Archila wrote in a note to clients that the rejection was due to treatment-related side effects in OCA clinical trials, where some patients had elevated levels of harmful cholesterol after receiving OCA treatment, which in turn increased their cardiovascular risk.
, given that many NASH patients are already overweight or have type 2 diabetes, such side effects can cause alarm among regulators.
the FDA's request for additional test data, Intercept may have to wait until at least the second half of 2022.
analysts believe such a long delay could erase some of Intercept's previously accumulated lead, giving other rivals, including Madrigal Pharmaceuticals and Viking Therapeutics, a chance to catch up.
sources: 1, Intercept's NASH drug drug faces its biggest delay yet 2, Intercept's NASH hopeful spurned by FDA, raising questions for other companies in the race.