Lecanemab gains FDA approval as Gantenerumab shows promise for Alzheimer's
Updated
Updated · WIRED · May 1
Lecanemab gains FDA approval as Gantenerumab shows promise for Alzheimer's
6 articles · Updated · WIRED · May 1
John Hardy said at WIRED Health that Lecanemab is available on Medicare in the US, while UK access remains limited to private patients.
He said Lecanemab slows rather than stops decline, potentially stretching Alzheimer's progression from about eight or nine years to 11 or 12.
Hardy said wider benefit now depends on earlier diagnosis, biomarker use and political investment in dementia services, as only about 60% of dementia diagnoses are actually Alzheimer's.
With new Alzheimer’s drugs slowing but not stopping the disease, could focusing on early diagnosis and prevention have a bigger impact than drug treatment alone?
Given the risks and limited access to anti-amyloid drugs, are new scientific theories and AI-driven discoveries poised to revolutionize Alzheimer’s care soon?
FDA Approval and Real-World Challenges of Lecanemab: 27% Slowing of Alzheimer's Progression Amid Safety and Access Barriers
Overview
Lecanemab received full FDA approval in July 2023 after the Clarity AD trial showed it slowed cognitive decline by 27% in early Alzheimer's patients. By early 2025, it was approved in over 10 countries, with new dosing options and a subcutaneous formulation under review to improve patient convenience. However, real-world data revealed higher safety risks, including a 22% incidence of brain swelling (ARIA) and 9% stroke risk, necessitating careful genetic testing and monitoring. In contrast, gantenerumab failed to slow symptoms in symptomatic patients due to high side effects limiting dosing but showed promise in preventing symptoms when given early. This highlights the importance of early intervention and drives development of next-generation therapies and combination treatments for Alzheimer's.