NASH front-runner Intercept, already delayed twice, faces another FDA setback

Intercept Pharmaceuticals, eager to market its potential nonalcoholic steatohepatitis (NASH) medicine obeticholic acid, will have to keep waiting. After two prior delays at the FDA, the company Friday disclosed another.

After discussions between the drugmaker and the FDA this week, the agency told Intercept its advisory committee meeting set for June 9 won’t work. The COVID-19 pandemic previously forced a rescheduling of the meeting from April, but the reasoning for this delay isn't pandemic-related.

Instead, Intercept is submitting additional data for the application, and the FDA's experts will need more time to review those data ahead of a committee hearing.

Naturally, Intercept expects the FDA to delay its scheduled June 26 decision date, too. The FDA is working to set another advisory committee date, Intercept said.

RELATED: Intercept's hotly anticipated NASH drug has to wait for its FDA hearing, thanks to COVID-19

It’s another setback for Intercept's hotly anticipated medicine for liver fibrosis caused by nonalcoholic steatohepatitis, eating away at its lead over potential NASH rivals. Analysts believe the NASH field can eventually generate up to $35 billion in annual sales, and behind Intercept are numerous biopharma players, including big names such as Gilead and Novartis.

Back in November, the company’s chief operating officer, Jerry Durso, told Wall Street analysts the company had made “significant progress” toward the rollout by starting payer talks and hiring sales staffers.  

Then the hits came. The FDA was set to decide on the drug—already approved as Ocaliva in primary biliary cholangitis—by March 26. In December, the agency set an advisory committee date for April 22, so the decision deadline had to follow suit. That delay was "broadly logistical," one analyst wrote.

By March, the COVID-19 pandemic forced another change of plans. That's when the FDA pushed its committee date back to June 9. And now, that date won't work either.

RELATED: Intercept aims to triple sales force as it gears up for potential NASH launch

The newest delay was “unanticipated,” Intercept’s CEO Mark Pruzanski said in a statement, but the company believes the new data “will be important in facilitating a more informed discussion” at the advisory committee meeting.

The drug application has scored an FDA priority review and a breakthrough designation. Intercept’s stock was down about 14% Friday morning on the news.