Intercept Wants More Time to Address EMA’s Questions Over Its NASH Treatment
EU Review Of Obeticholic Acid Began Around 18 Months Ago
The marketing application for obeticholic acid, Intercept’s potential new treatment for advanced fibrosis due to nonalcoholic steatohepatitis (NASH), was rejected in the US and now the company says it needs extra time to respond to questions about its EU filing.
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From biomarkers to treatment effect size, agency officials respond to some of more than a hundred questions that poured in during a webinar on development of drugs to treat the liver disease.
The US FDA complete response letter for Intercept’s obeticholic acid raised speculation that the agency might be rethinking approvable endpoints for NASH. But analysts generally think OCA’s unspectacular efficacy data is behind the decision.
Analysts believe that pan-EU authorization for Intercept Pharmaceuticals’ obeticholic acid for advanced fibrosis due to nonalcoholic steatohepatitis may come in the first quarter of 2021.