ICPT - Intercept resubmits application to FDA for OCA to treat liver disease

• Intercept Pharmaceuticals ( NASDAQ: ICPT ) said it resubmitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for obeticholic acid (OCA) to treat patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH).
• In NASH there is inflammation and liver damage, plus fat in the liver. Cirrhosis is scarring (fibrosis) of the liver.
• The resubmission was backed by data from the OCA NASH clinical development program, including two interim 18-month analyses from a phase 3 trial called REGENERATE .
• In September, a phase 3 trial, dubbed REVERSE, evaluating OCA had failed to meet its main goal.
• Intercept expects that the FDA will classify the application as a Class 2 resubmission with a review time of six months.
• OCA, which is already approved in the U.S. as Ocaliva for primary biliary cholangitis, is not yet approved for treating NASH by any regulatory authority, as per the company
• ICPT +0.98% to $13.60 premarket Dec. 23

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