Intercept Pharmaceuticals has withdrawn its marketing application for its liver fibrosis drug with the EMA as the biotech awaits additional trial data.
According to the NY-based biotech, the company has been working with the Committee for Medicinal Products for Human Use (CHMP) to potentially include data from the ongoing phase 3 REGENERATE study in the current regulatory review process. But, the data isn't expected until 2022 and the application timeline could not be extended any further.
The FDA, also requiring more safety and efficacy data, rejected the drug last year.
Intercept says advanced fibrosis due to nonalcoholic steatohepatitis (NASH) remains a significant unmet need in Europe, and remains hopeful that it can submit a new application to the EMA in the future.