In the News
With NASH results, Intercept Pharma will seek approval for first-ever treatment for fatty liver condition
Intercept Pharmaceuticals (ICPT) said Tuesday that an experimental medicine to treat the fatty liver disease known as NASH achieved its primary goal in a Phase 3 clinical trial, giving it a shot at becoming the first drug to treat the condition and turning it into a potential blockbuster commercial opportunity.
Based on the data collected from the clinical trial, Intercept said it would file marketing applications for the treatment in the U.S. and Europe in the second half of the year. The drug is called obeticholic acid, or OCA.
A competing NASH drug from Gilead Sciences failed a Phase 3 clinical trial last week, which means Intercept becomes the first drug maker to complete a pivotal Phase 3 study in patients with liver fibrosis due to NASH. That’s a victory unto itself, although there will be a debate about the overall balance of NASH benefit and safety risk associated with OCA.
The Phase 3 clinical trial enrolled 933 patients diagnosed with stage 2 or 3 (out of 4) liver fibrosis due to NASH, confirmed with a liver biopsy. The patients were randomized to treatment with one of two doses of OCA or a placebo for 18 months.