Intercept to go back to FDA with its NASH treatment application

·2 min read

(Reuters) -Intercept Pharmaceuticals Inc will resubmit its application for approval of its therapy for a chronic liver disease to the U.S. Food and Drug Administration, two years after the regulator had declined to give the green light.

The company is seeking approval for obeticholic acid to treat fibrosis or scarring associated with nonalcoholic steatohepatitis (NASH), a serious progressive liver disease caused by excessive fat accumulation in the liver.

Intercept said its treatment led to statistically significant reduction in fibrosis in patients with NASH after 18 months compared to the placebo, based on interim analysis.

Analysts, however, remained sceptical about the latest data and the drug's commercial potential.

Jefferies analyst Michael Yee said the new data did not add anything significantly new to what investors know about the treatment. "Overall, we expect investors to continue questioning the commercial opportunity in NASH."

The FDA declined to approve the therapy in 2020, saying the predicted benefit remains uncertain and does not sufficiently outweigh the potential risks. (https://reut.rs/3uy0Ysl)

At the time, the FDA recommended Intercept submit additional data from the late-stage study.

About 5% of adults in the U.S. have NASH, according to the American Liver Foundation, making it a lucrative opportunity for drugmakers, with giants such as Novo Nordisk and Pfizer developing treatments.

Intercept's treatment is already approved for another chronic liver disease called primary biliary cholangitis (PBC).

There still remains a challenging FDA safety and benefit framework for the company to navigate, B.Riley Securities analyst Mayank Mamtani said, adding that some investors would have preferred capital allocation staying focused on U.S. commercialization for PBC.

Shares of the company were flat at $15.28.

(Reporting by Mrinalika Roy and Leroy Leo in Bengaluru; Editing by Vinay Dwivedi and Krishna Chandra Eluri)