Intercept Pharmaceuticals Inc ICPT lost around 20% according to the FDA issued Briefing documents ahead of Adcomm’s scheduled May 19 meeting to review its liver disease candidate obeticholic acid (OCA). PDUFA target action date set for June 22, 2023.
The FDA briefing document highlighted an increased risk of diabetes and liver damage from the use of oral obeticholic acid (OCA) tablets to treat nonalcoholic steatohepatitis (NASH).
In the briefing documents, FDA reviewers raised concerns about the drug’s risk-benefit profile. “During the course of our review, the FDA identified moderate and serious benefits Risks of OCA to treat NASH,” they wrote.
“Study results for obeticholic acid suggest that it causes multiple off-target side effects that require multiple risk reduction strategies with low probability of efficacy,” the FDA added.
FDA officials noted that while the 25 mg dose was superior to placebo in reducing liver scarring in NASH patients at 18 months, they added that there was uncertainty as to how the surrogate endpoint of the “biomarker” clinical results can be meaningfully implemented.
In 2016, OCA, called Ocaliva, was approved for the treatment of primary biliary cholangitis (PBC), a chronic liver disease in which the bile ducts in the liver are slowly destroyed.
The Company is actively pursuing its OCA launch preparation activities in precirrhotic fibrosis due to NASH.
Price promotion: ICPT shares are down 16.90% at $13.48 at last check on Wednesday.