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Year Of NASH Upheaval Means Incremental Data At AASLD

Firms Are Retrenching, But There Are Signs Of Progress

 
• By Joseph Haas

With still no approved therapy for non-alcoholic steatohepatitis, Intercept, Madrigal, Inventiva and others used the liver meeting to build the cases for their NASH candidates.

Urban Car Road Traffic Congestion Aerial View
Many paths to the first NASH drug therapy remain viable in a year of upheaval

This year began with the expectation of the first drug approval in non-alcoholic steatohepatitis, with a number of other Phase III programs right on the lead product’s heels. But instead, the year is closing out with uncertainty – and the datasets presented at the American Association for the Study of Liver Diseases’ 13-16 November virtual annual meeting reflected that.

Instead of approval for NASH, Intercept Pharmaceuticals, Inc.’s FXR agonist obeticholic acid (OCA) got a complete response letter from the US Food and Drug Administration on 29 June. (Also...

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