The Conflicting Lessons Of Aduhelm
US FDA is understandably feeling vindicated about the decision to use beta amyloid as a surrogate marker in Alzheimer’s. But the agency needs to be careful because critics of its landmark accelerated approval decision for Aduhelm are not arguing about the science.
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Medicare is not envisioning an overly burdensome process to fulfill its requirement for a registry as a condition for coverage of ‘fully’ approved beta amyloid Alzheimer’s therapies, the head of the agency tells Congress. Biogen and Eisai still hope to have the registry obligation removed altogether.
The FDA was mum on the expertise that it appears to be lending the payer, but Commissioner Robert Califf reiterated that communication between the agency and CMS is increasing.
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.