Aduhelm Shows Need For More FDA Transparency On Approval Decisions, Surrogate Endpoints, Critics Say
But Center for Drug Evaluation and Research leaders stand their ground at a National Academies meeting, asserting the Phase III data for a different Alzheimer’s drug, Leqembi, are likely to confirm their views on utility of amyloid as a surrogate endpoint.
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The US Medicare agency’s restrictive coverage policy for Alzheimer’s antibodies is a clear threat to the FDA accelerated approval pathway. Now the payor is going to try a different approach to strengthen the pathway.
Transparency In Alzheimer’s: AdComm Expected On Regular Approval For Eisai/Biogen’s Leqembi
While a US FDA advisory committee would focus on efficacy and safety data from Leqembi’s Phase III CLARITY-AD trial, it likely also would provide a public forum for relitigating Audhelm’s accelerated approval and the evidence needed to formally validate amyloid plaque reduction as a surrogate.
‘No Simple Formula’: US FDA Decisions On Surrogate Endpoints Are Complex, Case-Specific
Office of New Drugs’ Peter Stein runs down the types of evidence and other considerations weighed in determining that a surrogate is reasonably likely to predict clinical benefit; however, some panelists at a National Academies meeting say the agency needs to increase transparency around its thinking on surrogates that can support accelerated approval.