Ad Comm review approaches for Intercept's lead product candidate

• Intercept Pharmaceuticals (NASDAQ:ICPT) is up 10% premarket on increased volume ahead of Thursday's meeting of the FDA's Gastrointestinal Drugs Advisory Committee to review the company's New Drug Application (NDA) seeking approval of obeticholic acid oral tablets, in combination with ursodeoxycholic acid (UDCA), for the treatment of adults with primary biliary cirrhosis (PBC) who fail to respond adequately to UDCA or as monotherapy in adults unable to tolerate UDCA.
• Draft questions 
• FDA briefing doc
• Errata to FDA briefing doc
• Company briefing doc
• Errata to company briefing doc 
• Update: The buying appears to be stoked by the clarity around the endpoints in the Phase 3 study, 747-301, which measured OCA's efficacy by the reduction in a liver enzyme called alkaline phosphatase (ALP) or total bilirubin (TB). Eligible participants had to have elevated values in at least one of the biomarkers. Most of the subjects, though, had elevated ALP levels but normal TB. The link between specific reductions in ALP and clinical benefit have not be conclusively established, so the FDA expressed doubt that ALP alone would be sufficient to demonstrate efficacy. Later in the FDA's briefing doc, the author provides the details from an analysis of 5,000-person registry study that supports the use of ALP as an indicator of efficacy (Section 4).