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 French biotech was firmly on the ropes last year after elafibranor joined the long list of failures for NASH but the promise it has shown in primary biliary cholangitis has persuaded Ipsen to part with a hefty upfront fee.
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.