DJ Intercept Shares Fall as FDA Rejects Obeticholic Acid New Drug Application
By Colin Kellaher
Intercept Pharmaceuticals Inc. on Monday said the U.S. Food and Drug Administration has indicated it won't approve the company's new drug application for obeticholic acid in its current form, sending the company's shares down sharply in premarket trading.
The New York biopharmaceutical company said it received a complete response letter from the FDA in which the agency said it found the predicted benefit of obeticholic acid remains uncertain and doesn't sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to nonalcoholic steatohepatitis, a chronic liver condition commonly known as NASH.
Intercept said the FDA recommended the company submit additional data from its current study of the drug in support of potential accelerated approval, and that the long-term outcomes phase of the study should continue.
Intercept said it is disappointed with the FDA's decision, adding it believes the data it has submitted meet the requirements of the agency's guidance and support the drug's positive benefit-risk profile.
The company said it plans to meet with the FDA as soon as possible to review the letter and to discuss its options for an efficient path to approval.
Shares of Intercept, which closed Friday at $77.49, tumbled 33% to $52.30 in premarket trading.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 29, 2020 07:25 ET (11:25 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.