NASH Drug Development: Experts Argue The Case For Noninvasive Tests As Surrogate Endpoints For Approval
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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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.
Using real-world evidence and potentially a Phase III trial with a fixed-dose combination, Intercept is refocusing on fulfilling postmarketing requirements for obeticholic acid’s current indication in primary biliary cholangitis after ending development of the drug in nonalcoholic steatohepatitis due to FDA’s second rejection of accelerated approval.
Although US FDA reaffirmed its support of surrogate endpoints described in a 2018 draft guidance on NASH fibrosis, advisory committee members questioned the link to clinical benefit and said obeticholic acid’s serious risks made it difficult to consider the effect on the surrogate in a vacuum.