10:43 AM
Dec 05, 2018
 |  BC Extra  |  Politics & Policy

FDA NASH guidance charts course for surrogate endpoints tied to biopsies

Four companies with products in Phase III testing to treat non-alcoholic steatohepatitis are well positioned to meet endpoints that could support accelerated approval, according to requirements outlined in new FDA draft guidance. However, the guidance doesn’t do much to address questions about how imaging endpoints and biomarkers could help reduce requirements for invasive biopsies in NASH trials.

The draft guidance, which was released Monday, addresses general considerations as well as specific issues for Phase II, Phase III and pediatric trials to treat non-cirrhotic NASH...

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