STAT+: With ‘do-over’ NASH results, Intercept will seek approval for first-ever treatment for fatty liver condition
Intercept Pharmaceuticals said Thursday that an extensive re-analysis of a large clinical trial involving its experimental treatment for the fatty liver disease known as NASH once again achieved its primary efficacy goal.
The company intends to use the new data to resubmit a marketing application in the U.S., although its approvability is likely to remain a hotly debated question.
