(Reuters) – Shares of Intercept Pharmaceuticals Inc fell 16% on Monday over concerns about the prospects of the company’s drug to treat a type of fatty liver disease after the regulator’s advisory panel voted to defer an accelerated approval.
A panel of advisers to the U.S. Food and Drug Administration said on Friday study data suggested that the benefits of Intercept’s drug, obeticholic acid (OCA), did not outweigh the risks in patients with NASH (non-alcoholic steatohepatitis) and fibrosis, or scarring.
SVB Securities analyst Thomas Smith believes the company may discontinue the NASH program and pivot its focus on only primary biliary cholangitis (PBC), a chronic liver disease for which OCA was approved in 2016 and is sold under brand name, Ocaliva.
NASH, a progressive fatty liver disease, affects about 5% of adults in the U.S., according to the American Liver Foundation, and presents an unmet need with no approved drugs after numerous clinical failures by several drugmakers.
Drugmakers such as Novo Nordisk, Madrigal Pharmaceuticals and Akero Therapeutics are also developing treatments for the disease, and competition is expected to increase by the time Intercept will be ready with its pivotal trial data.
The best next step for Intercept at this point would be to immediately halt an ongoing late-stage trial to see if there are any encouraging signals in the larger dataset that could open the door for a potential submission for full approval, Baird analyst Brian Skorney said.
“Beyond that last glimmer of hope in NASH”, Skorney said, the company can only maximize its market share in treating PBC.
Intercept’s PBC drug use, however, was restricted in 2021 in patients with advanced cirrhosis of the liver because of the potential for serious harm.
(Reporting by Leroy Leo in Bengaluru; Editing by Shinjini Ganguli)
