ICPT - Intercept slips 26% as FDA comments on NASH therapy ahead of AdCom meeting

2023-05-17 09:51:01 ET

Intercept Pharmaceuticals ( NASDAQ: ICPT ) lost ~26% in the morning hours Wednesday after the FDA issued briefing documents ahead of a meeting of its independent advisors on the marketing application for the company's liver disease candidate Obeticholic Acid (OCA).

In March, Intercept ( ICPT ) announced that the FDA's Gastrointestinal Drugs Advisory Committee is scheduled to meet on May 19 to discuss the approvability of OCA, targeted at patients with nonalcoholic steatohepatitis (NASH).

FDA is expected to finalize its decision on or before June 22, 2023, the target action date the agency issued for the company's New Drug Application (NDA). OCA, a farnesoid X receptor ( FXR ) agonist, is already marketed as Ocaliva for the rare autoimmune disease primary biliary cholangitis.

The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations.

In the briefing documents, the FDA reviewers raised concerns about the drug's risk-benefit profile despite the unmet need in NASH. "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 low likelihood of effectiveness," the FDA added.

More on Intercept

• Intercept Pharma off 11% on Q1 misses
• Navigating The NASH Storm: Intercept Pharmaceuticals' Uncertain Voyage
• Intercept: FDA Accepts Application For Ocaliva In NASH

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