Lecanemab granted full approval by US FDA
The US FDA has converted lecanemab from accelerated approval to traditional approval.
Lecanemab, an anti-amyloid monoclonal antibody used to treat early-stage Alzheimer’s, has been granted full approval by the US FDA. The drug, sold under the brand name Leqembi and developed by Eisai (Tokyo, Japan) and Biogen (MA, USA), was approved via the Accelerated Approval pathway in January 2023 and has now been fully approved via the traditional pathway.
This approval makes lecanemab the first drug aimed at slowing the progression of Alzheimer’s to be granted full approval by the US FDA. This opens the door to Medicare coverage, although due to the $26,500 price tag and Medicare only covering 80% of the cost, people could still face large bills.
Lecanemab was originally approved through the Accelerated Approval pathway, which is intended to provide earlier access to potentially valuable treatments when they are shown to have an effect on a surrogate endpoint that is likely to predict a clinical benefit for patients. After reviewing the Phase III trial data, which found that lecanemab slowed cognitive decline by 27%, an FDA advisory panel voted six to zero in favor of converting the approval.
Speaking to the Science Media Centre, David Curtis, Honorary Professor at University College London (UK), commented: “This really is remarkable news. Certainly, there are concerns about serious side effects and questions about the balance between clinical benefits and the overall costs of treatment. Nevertheless, this decision badges Alzheimer’s disease as an illness which can potentially be treated or prevented, rather than simply endured.”
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