Lecanemab Conversion From Accelerated To Full Approval Could Be Among Fastest Ever
Executive Summary
Biogen/Eisai’s Phase III data is on track for a Q1 2023 submission, potentially just weeks after lecanemab is expected to gain accelerated approval for early Alzheimer’s.
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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.
Tailored Alzheimer’s Indication Let Lecanemab Avoid Stronger Safety Warning, REMS
Eisai says ‘narrow’ indication negated need for REMS on amyloid-related imaging abnormalities and hemorrhages in the brain. Unusual nature of accelerated approval and confirmatory trial timing means safety data from the Phase III is barely mentioned in label.
Eisai Pricing For Lecanemab Reflects Concern With Medicare ‘Sustainability,’ ‘Giving Back,’ Firm Says
Despite internal modeling indicating lecanemab offers a ‘societal value’ of around $37,600 per year, the company has decided on a list price of around $26,500 annually to moderate the impact on Medicare and patients.