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NASH Drug Development: Experts Argue The Case For Noninvasive Tests As Surrogate Endpoints For Approval

 
• By Sue Sutter

However, FDA officials appear skeptical that imaging-based and circulating biomarkers are ready for prime time when it comes to supporting accelerated approval of drugs for noncirrhotic nonalcoholic steatohepatitis.

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An FDA official cautioned against trying to build a surrogate on a surrogate. • Source: Shutterstock

US Food and Drug Administration officials appeared skeptical that current evidence supports the use of noninvasive tests as surrogate endpoints for approval of drugs to treat noncirrhotic nonalcoholic steatohepatitis, despite a push from researchers and clinicians in the field who assert the traditional histology-based surrogate endpoints are falling short.

Key Takeaways

  • Current histology-based surrogate endpoints used for NASH drug development are problematic because they require liver biopsies and meaningful changes in response to treatment can be hard to discern.

  • NASH clinicians and researchers believe data are available to support use of noninvasive tests as surrogate endpoints for accelerated approval and suggest that panels of NITs should be systematically incorporated into large trials to demonstrate that they can predict clinical outcomes

At a recent two-day FDA meeting on use of biomarkers for diagnosing and assessing treatment response in noncirrhotic NASH trials, clinical experts discussed limitations of the current

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