Leqembi Safety: Label Has Distinct MRI Schedule But Follows Aduhelm On ARIA Management
With the second amyloid-targeting antibody for treatment of Alzheimer’s, US FDA opted for a class-wide approach to management of amyloid-related imaging abnormalities, but with a product-specific MRI monitoring schedule that differs from that of Aduhelm.
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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.
Leqembi Clinical Development: Aduhelm Opened The Door For Accelerated Approval
Timeline of lecanemab’s clinical development shows how, almost three years after telling Eisai and Biogen that their Phase II results did not support regular or accelerated approval, the FDA review division reversed course following its decision to approve aducanumab on a surrogate endpoint.
Eisai’s Lecanemab: US FDA Showed Flexibility On Clinical Endpoint Results, Safety Database Size
Alzheimer’s drug’s failure to meet Phase II endpoint did not preclude accelerated approval in light of statistically significant reduction in amyloid plaque and ‘generally consistent and favorable results on clinical endpoints.’ Size of six-month safety database also fell shy of ICH guidelines.