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NASH Accelerated Approval: US FDA Remains Confident In Pathway For Liver Disease

 
• By Michael McCaughan

A two-day workshop on potential biomarkers in NASH provided a forum for US FDA officials to offer implicit reassurance to drug developers: the agency stands behind its guidance on Accelerated Approval for the liver disease, despite the rejection of the first application seeking to use that approach.

MASH-NASH
NASH (non-alcoholic steatohepatitis) is now also known as MASH (metabolic dysfunction associated steatohepatitis). • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

US FDA review officials believe the experience with post-marketing cardiovascular outcomes trials in diabetes is a strong indication that it will be possible to complete rigorous, long-term confirmatory studies for drugs that receive Accelerated Approval to treat NASH.

“While there are clear challenges to feasibly and reliably carrying out these clinical benefit trials after an Accelerated Approval, I do believe that they can be successfully completed in a timely and reliable manner,” Office of Biostatistics Associate Director for Statistical Science and Policy Gregory Levin said during a September 

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