ICPT - Intercept to resubmit for FDA approval of NASH candidate after new analysis

• The commercial stage biotech Intercept Pharmaceuticals ( NASDAQ: ICPT ) announced on Thursday that the company would resubmit a new drug application to the FDA for its NASH candidate obeticholic acid ( OCA ) after a new interim analysis in a pivotal trial indicated positive results.

• Nonalcoholic steatohepatitis (NASH) is a liver disease with no currently approved medications. The excessive fat accumulation in liver can cause chronic inflammation leading to fibrosis (scarring) and eventually resulting in cirrhosis, liver failure, cancer and death.

• The new analysis from the ongoing Phase 3 REGENERATE trial showed that OCA 25 mg met the primary endpoint Intercept ( ICPT ) said, adding that with these results, the company will resubmit its marketing application for OCA targeting patients with liver fibrosis due to NASH.
• “…..we now have two positive, statistically significant results for this primary endpoint from our pivotal REGENERATE trial,” Chief Executive Jerry Durso remarked.
• “We look forward to our meeting with FDA later this month to discuss the resubmission of our NDA for OCA in fibrosis due to NASH,” he added.
• This is a developing story. Check back for more updates.

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