In another blow to Intercept, the FDA is investigating Ocaliva for potential risk of liver disorder

Just a month before handing Intercept Pharmaceuticals a CRL for Ocaliva in NASH, the FDA began evaluating the drug for a potential risk of liver disorder in primary biliary cholangitis (PBC) patients. The probe, which launched in May, was disclosed by the company deep down in their latest quarterly report filed with the SEC, and had not otherwise been communicated publicly by Intercept until reports surfaced this week.