EMA CHMP recommends approval of Ocaliva (obeticholic acid) for primary biliary cholangitis- Intercept Pharmaceuticals

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization of the Company's Marketing Authorization Application (MAA) for Ocaliva (obeticholic acid or OCA), from Intercept Pharmaceuticals, an FXR agonist, for the treatment of primary biliary cholangitis (PBC) conditional to the company providing further data post-approval to confirm benefit.

The MAA submission included data from more than 1,500 subjects exposed to at least a single dose of OCA. The positive opinion of the CHMP was based on efficacy and safety data derived from three randomized double-blind, placebo-controlled clinical trials in patients with PBC evaluating the effect of OCA on ALP and bilirubin. The MAA submission was also supported by two clinical databases that include more than 10,000 patients from the Global PBC Study Group and UK-PBC Group, both independently confirming that achieving lower ALP and/or bilirubin levels is significantly correlated with increased transplant-free survival.