脂肪肝炎靶向药物之奥贝胆酸

(Obeticholic acid, Obetix, Ocaliva) is the only drug approved by the US FDA for the treatment of primary biliary cirrhosis (PBC) in the past 20 years. It can significantly improve the biochemical indicators of PBC patients who have poor response or intolerance to ursodeoxycholic acid (UDCA) treatment, delay disease progression, and improve survival rates.

Intercept Pharma announced on February 19 that the study of obeticholic acid in alcoholic steatohepatitis has obtained the top-line data of the Phase III clinical trial. In a randomized, double-blind and placebo-controlled multi-center trial, 931 NASH patients with secondary or tertiary liver fibrosis were included, taking doses of obeticholic acid 10 mg/day, 25 mg/day, and placebo.

Data analysis during the administration showed that after 18 months of treatment, taking obeticholic acid 25 mg achieved the primary endpoint and significantly improved the patient's liver fibrosis compared with placebo.

As early as 2015, Intercept published the results of the phase II FLINT trial, which showed that 283 patients achieved the primary endpoint (a 2-point reduction in NAS score without worsening of fibrosis) after 72 weeks of treatment (obeticholic acid vs placebo, p=0.0004); NASH symptoms no longer worsened: 18% vs 5% (obeticholic acid vs placebo, p=0.0004). 0.0014); fibrosis improved by at least two grades, 39% vs 21% (obeticholic acid vs placebo p = 0.007).