The U.S. Food and Drug Administration (FDA) has approved a self-injectable version of lecanemab, a drug designed to slow the progression of early Alzheimer's disease. This new formulation, administered weekly at home in approximately 15 seconds, marks a significant shift from the previous hour-long intravenous infusion.
This development raises hopes that the drug, previously burdened by resource-intensive delivery methods that impacted cost-effectiveness, could become more accessible. Charities have expressed optimism that this change will help lecanemab meet affordability criteria for wider availability, potentially including on the UK's National Health Service (NHS).
Lecanemab targets amyloid, a protein that accumulates in the brains of individuals with Alzheimer's, aiming to clear these buildups and slow cognitive decline. Clinical trials presented in December indicated that lecanemab could delay the progression of the disease by up to 8.3 years in patients with early-stage Alzheimer's and low levels of amyloid protein.
The injectable version is expected to be available in the US starting next month. The manufacturer, Eisai, stated that the weekly jab is anticipated to be as effective as the intravenous treatment with a similar safety profile, while reducing the strain on healthcare systems. Patient feedback on the new formulation has been largely positive, with 97% expressing satisfaction due to its speed, convenience, and less painful administration.
While the FDA approval is a significant step, experts emphasize the need for healthcare systems to be prepared for the delivery of such treatments. Challenges remain in diagnosing Alzheimer's early and ensuring healthcare services have the necessary staff and tools to manage new therapies effectively. The list price for the subcutaneous treatment in the U.S. is approximately $376 per auto-injector, equating to a yearly induction treatment cost of about $39,200 per patient, excluding delivery costs. Both IV and subcutaneous treatments can transition to less frequent maintenance regimes after 18 months, reducing annual costs.