Intercept Drug’s Market Standing In PBC Undermined By Safety Woes
Ocaliva Now Contraindicated In Advanced Cirrhosis
A second FDA safety labeling update for Intercept’s Ocaliva might open a market opportunity in second-line PBC for Phase III candidates at CymaBay and Genfit.
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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.
Revenues are still elusive for a surprising number of the novel drugs approved by the FDA five years ago. Emergent safety issues and confirmatory clinical trial failures were less common than lack of competitiveness as the main reason for revenue weakness.
After last year’s Phase III failure in NASH, Genfit sees big opportunity in acute on chronic liver failure (ACLF), potentially with antiviral NTX. Its ongoing Phase III program in PBC as also is a potential revenue-driver.