Intercept Pharmaceuticals, Inc.
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Latest From Intercept Pharmaceuticals, Inc.
Biotech is determining which of its mid-stage FXR candidates – MET409 and MET642 – will offer the best overall profile to take into Phase IIb. It is also studying ‘409 in combination with Jardiance and will test the FXR class in inflammatory bowel disease.
When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval
More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.
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.
The company pointed to cirrhosis benefit and less pruritis in a pooled analysis presented at EASL, which will help it will take on Intercept in primary biliary cholangitis on tolerability, cirrhosis benefit.