FDA Tells Intercept Pharmaceuticals No on Its NASH Drug Candidate -- for Now
Millions of people with a progressive liver condition will have to wait longer for a treatment for it to become available. The FDA has refused to approve an application for obeticholic acid (OCA) for patients with advanced-stage non-alcoholic steatohepatitis (NASH). Instead, the agency told the compound's owner, Intercept Pharmaceuticals (NASDAQ: ICPT), to try again and come back with more evidence that OCA can safely improve outcomes for people with NASH-related liver fibrosis.
The FDA sent Intercept Pharmaceuticals what's called a complete response letter (CRL) asking for more evidence of the drug's efficacy and safety. This isn't an outright denial, but it does mean the company will need to produce more evidence the treatment's efficacy outweighs its potential safety issues.
Image source: Getty Images.
Source Fool.com
