Ocaliva resubmitted to FDA for NASH.- Intercept Pharma
Intercept Pharmaceuticals has announced that it has resubmitted a new drug application (NDA) to the FDA seeking approval for Ocaliva (obeticholic acid or OCA) to treat patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH).
The resubmission is supported by a robust body of evidence from the OCA NASH clinical development program, including two positive interim 18-month analyses from the pivotal Phase III REGENERATE study in patients with pre-cirrhotic liver fibrosis due to NASH.
In both REGENERATE analyses, treatment with OCA 25 mg demonstrated a statistically significant improvement in liver fibrosis by at least 1 stage without worsening of NASH—an improvement that was more pronounced in individuals with more advanced disease at baseline. Other measures of liver disease, including blood levels of liver enzymes and noninvasive measures of liver stiffness, demonstrated dose-dependent improvements after 18 and 48 months of therapy.
Further, a detailed analysis of the largest safety database in NASH demonstrated a monitorable and manageable safety and tolerability profile that supports the potential chronic administration of OCA. The company anticipates that the FDA will classify this application as a Class 2 resubmission with a PDUFA target review time of 6 months.
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