Intercept Pharmaceuticals and its closely watched nonalcoholic steatohepatitis (NASH) candidate have hit another snag, this one courtesy of the coronavirus pandemic.
The FDA has put off an advisory committee review of the company's obeticholic acid drug, now the lead horse in the hotly contested NASH race. Sold for another indication as Ocaliva, the med would be the first approved to treat the increasingly prevalent liver disease.
And it's the drug's second scheduling snafu. It had been due for an FDA decision March 26, but in December, the FDA set an advisory panel meeting in April. Now, the confab is "tentatively scheduled" for June 9 because of the pandemic, Intercept said in a wide-ranging business update Thursday.
Despite the hearing delay, the drug's June 26 decision date at the agency remains, Intercept said.
Intercept is seeking approval to treat NASH patients who've developed fibrosis in their livers, and the drugmaker has already started launch prep, an exec said in November. The drug is already approved as Ocaliva in primary biliary cholangitis (PBC), and, in November, Chief Operating Officer Jerry Durso said the company had made “significant progress” toward the NASH launch.
At the time, the company had kicked off payer talks—with FDA support—and hired a sales team, he said.
The company plans to target 15,000 hepatologists and gastrointestinal specialists for the U.S. launch. It’s been working with about a third of them on the drug’s original indication with 55 territory business managers. For NASH, Durso said the company wanted to triple its sales force—plus add contract sales reps.
The drug application's initial delay was "broadly logistical," Cantor Fitzgerald analyst Alethia Young wrote at the time. Intercept had a decision date set for late March, but the agency didn't schedule its hearing until April. The FDA's decision logically couldn't come before the hearing to review the application.
Outside of the rescheduling update, Intercept said its existing PBC business has performed well in the first quarter. And, like many other companies, its employees are working from home.
As for clinical studies, the company’s ongoing NASH studies are fully enrolled, and the company is focusing on supporting patients and trial sites. In certain PBC studies, Intercept is pausing screening and randomization of patients.
The hearing rescheduling is just one example of many of a drugmaker’s R&D, regulatory or business operations being disrupted by the global pandemic. This week, several drugmakers disclosed trial delays, and Bristol Myers Squibb said it’s putting off the launch for new multiple sclerosis drug Zeposia.