Intercept Resubmits New Drug Application to U.S. FDA for Obeticholic Acid in Patients with Liver Fibrosis

NDA supported by robust NASH clinical development program

Two positive interim analyses from the Phase 3 REGENERATE study

NDA includes detailed safety analysis of 2,477 patients with nearly 1,000 patients on study drug for 4 years

MORRISTOWN, N.J., Dec. 23, 2022 (GLOBE NEWSWIRE) — Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on innovative therapies for chronic liver diseases, has announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for obeticholic acid in patients with liver fibrosis.

The NDA is supported by a robust clinical development program for non-alcoholic steatohepatitis (NASH), including two positive interim analyses from the Phase 3 REGENERATE study. The submission includes a detailed safety analysis of 2,477 patients, with nearly 1,000 patients who have been on the study drug for up to 4 years.

This resubmission represents a significant milestone for Intercept Pharmaceuticals and a potential breakthrough in the treatment of liver fibrosis, a serious condition that affects millions of people worldwide. Obeticholic acid has shown promising results in clinical trials, and if approved by the FDA, it could provide a much-needed therapeutic option for patients with NASH and liver fibrosis.

How will this affect me?

If obeticholic acid is approved by the FDA for the treatment of liver fibrosis, it could potentially offer a new treatment option for individuals suffering from this condition. Patients with NASH and liver fibrosis may benefit from improved outcomes and quality of life with access to this new therapy.

How will this affect the world?

The approval of obeticholic acid for liver fibrosis could have a significant impact on the global healthcare landscape. With millions of people worldwide affected by NASH and liver fibrosis, the availability of a new treatment option could help address an unmet medical need and reduce the burden of these chronic liver diseases on healthcare systems and society as a whole.

Conclusion

The resubmission of the NDA for obeticholic acid by Intercept Pharmaceuticals marks a promising development in the field of liver fibrosis treatment. If approved, this innovative therapy has the potential to improve outcomes for patients with NASH and liver fibrosis, offering hope for a brighter future in the fight against chronic liver diseases.