The United States 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 allows patients to administer the medication at home weekly, a significant shift from the previous intravenous infusion method that required lengthy hospital visits.
The injectable drug, which takes approximately 15 seconds to administer, is expected to be available in the U.S. starting next month. This development aims to reduce the burden on patients, healthcare providers, and medical facilities associated with the hour-long IV infusions. The FDA's approval allows patients to begin treatment directly with the injectable form, bypassing the need for initial infusions.
Lecanemab works by targeting amyloid, a protein that accumulates in the brains of individuals with Alzheimer's disease. By binding to and helping to clear these amyloid deposits, the drug is designed to slow cognitive decline. Clinical trials have indicated that lecanemab can 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.
Charities in the UK have expressed hope that this approval will pave the way for the drug's availability on the National Health Service (NHS). The intravenous version of lecanemab was previously deemed not to offer value for money by the UK's National Institute for Health and Care Excellence (NICE), partly due to the resource-intensive delivery method. While lecanemab is available privately in the UK via IV infusion, the new injectable form could address these cost and logistical barriers.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is expected to review an application from the drug's manufacturer, Eisai. Hilary Evans-Newton, chief executive of Alzheimer's Research UK, stated that an injectable version would be a "game-changer" for patient convenience and administration affordability for health services. However, concerns remain regarding the readiness of the UK's healthcare system to support new dementia treatments, including the need for earlier diagnosis and increased staffing.
The list price for the weekly subcutaneous treatment in the U.S. is approximately $375 per auto-injector, equating to an induction treatment cost of around $39,000 per patient per year. This compares to the IV treatment's cost, which is around $26,000 annually per patient, excluding administration costs. Both treatments can transition to a less frequent maintenance regimen after 18 months, reducing long-term costs.
NICE is expected to deliver its findings on the drug next month after reviewing new evidence following an appeal of its initial decision. A spokesperson for the Department of Health and Social Care in the UK stated that the government is investing in diagnostics and workforce expansion to improve patient care.