Intercept after new analysis will resubmit obeticholic acid for FDA approval to treat liver fibrosis due to NASH

The excessive fat accumulation in the liver can cause chronic inflammation in NASH leading to fibrosis (scarring) and eventually resulting in cirrhosis, liver failure, cancer, and death.

The analysis from the ongoing Phase III REGENERATE trial showed that OCA 25 mg met the primary endpoint and the company will resubmit its marketing application for OCA targeting patients with liver fibrosis due to NASH. According to data, the intent-to-treat (ITT) population from the ongoing study met the main goal, achieving at least one stage of fibrosis improvement with no worsening of NASH at month 18, consistent with the original analysis of the trial.

22.4% of subjects who received OCA at 25 mg were found to have reached the primary endpoint compared to 9.6% on placebo (p<0.0001. meanwhile, based on safety data from 2,477 subjects who took at least one dose of placebo, oca 10 mg, or oca 25 mg, the incidence of pruritus stood at 24% in placebo, 33% in oca 10 mg and 55% in oca 25 mg. pruritus was found to be the most common treatment-emergent adverse event (teae) that led patients to discontinue the treatment.

Intercept had asked the FDA to approve its drug as a NASH treatment, but the FDA rejected the application, not being convinced that OCA’s purported benefits outweighed its potential risks, and therefore they wanted to more data to be collected from REGENERATE before undertaking a regulatory review.