Intercept Launches Second NDA for Liver Fibrosis Treatment

Intercept Pharmaceuticals has resubmitted its new drug application (NDA) for obeticholic acid (OCA) for the treatment of patients with pre-cirrhotic liver fibrosis secondary to nonalcoholic steatohepatitis (NASH).

The resubmission is supported by new positive interim analyses of the ongoing phase 3 REGENERATE study, including a safety analysis of 2,477 patients, 1,000 of whom have been taking the drug for four years.

The analyses showed that OCA 25 mg showed a statistically significant improvement in liver fibrosis without worsening of NASH. Patients with more advanced baseline disease reaped the biggest benefit, the company said, although it didn’t provide any detailed numbers.

This is Intercept’s second shot on goal for the molecule. The company’s first NDA submission was in June 2020, with an indication for patients with liver fibrosis due to NASH. The FDA rejected that with a Complete Response Letter, noting that the submitted data did not clearly show the drug’s benefit.

The company anticipates that the FDA will review the resubmitted NDA within six months.