Intercept’s NASH decision delayed by FDA, but don’t panic: analysts

Intercept Pharmaceuticals has been gearing up for the potential launch of its nonalcoholic steatohepatitis (NASH) med, but now its wait looks a little longer.

While the FDA was originally due to decide on the company’s application for obeticholic acid by March 26, 2020, Intercept said Friday that date wouldn’t work. That’s because the agency has set an advisory committee hearing to review the application April 22.

The company didn’t announce a new decision date for the candidate—already on the market as Ocaliva to treat primary biliary cholangitis—but it’ll logically have to come after the April hearing.

Analysts aren’t very worried about the delay. Cantor Fitzgerald’s Alethia Young wrote that her team expects a two- or three-month delay, but that the extra wait doesn’t hurt the med’s chances of approval. Instead, the delay is “broadly logistical,” and her team believes the agency’s move to set an AdComm hearing for next year is a “positive update,” she said.

RBC Capital Markets analyst Brian Abrahams made similar points in a note to clients. After speaking with the company, he believes the delay is about “scheduling logistics … rather than any specific concerns or issues with the filing or drug.” The delay will push out potential revenue generation but provides “clarity” about the application, he added.

In the meantime, Intercept has been open about its launch preparations. On a recent conference call, Intercept Chief Operating Officer Jerry Durso said the company has initiated payer talks and hired an internal sales force to support the rollout. The NASH approval would be for patients who’ve developed fibrosis in their livers, and Intercept has already launched its unbranded disease education push.

https://www.fiercepharma.com/pharma/intercept-s-nash-decision-date-at-fda-pushed-back-but-don-t-panic-analysts