Intercept Pharmaceuticals Inc ICPT lost around 20% after the FDA issued briefing documents ahead of the adcomm meeting scheduled for May 19 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 injury from using the obeticholic acid (OCA) oral tablets to treat nonalcoholic steatohepatitis (NASH).
In the briefing documents, the FDA reviewers raised concerns about the drug's risk-benefit profile. "During the course of our review, FDA identified modest benefits and serious risks of OCA for treatment of NASH," they wrote.
"Trial results for obeticholic acid indicate it causes multiple off-target effects that require multiple risk mitigation strategies with a low likelihood of effectiveness," the FDA added.
The FDA staff noted that while the 25 mg dose showed superiority compared to the placebo in terms of reduction in liver scarring in NASH patients after 18 months, but added that there was uncertainty on how the surrogate endpoint of the 'biomarker' might translate into meaningful clinical outcomes.
In 2016, OCA, dubbed Ocaliva, was approved for primary biliary cholangitis (PBC), a chronic liver disease in which the bile ducts in the liver are slowly destroyed.
The company is actively progressing with its launch readiness activities for OCA for pre-cirrhotic fibrosis due to NASH.
Price Action: ICPT shares are down 16.90% at $13.48 on the last check Wednesday.
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