1. The FDA cleared a subcutaneous maintenance version of lecanemab, allowing patients with AD (Alzheimer’s disease) to continue treatment at home.
2. This shift could ease pressure on infusion clinics while still requiring careful ARIA monitoring.
On August 29, the FDA approved a new subcutaneous formulation of lecanemab, the antibody marketed as Leqembi, designed for maintenance therapy in AD, according to Reuters. Instead of returning every two weeks for intravenous infusions, patients who have completed the 18-month induction course can now self-administer injections at home, as detailed in the Eisai announcement. The drug will be supplied in prefilled autoinjectors, priced at about 19,500 dollars annually, which Eisai says reflects the lower cost of subcutaneous delivery. For memory clinics already managing tight infusion schedules, this change could free up capacity and reduce logistical strain. Caregivers may also find it easier to keep patients on therapy when travel and infusion center visits are reduced. Still, ARIA, expanded as amyloid related imaging abnormalities, remains a safety concern, and MRI protocols must stay in place. Eisai has already filed a rolling submission for a subcutaneous starting-dose regimen, noted in a September 2 update, suggesting more flexibility may be on the way. For neurologists, the science hasn’t changed, but the delivery method could influence adherence and access. Health systems will need to update education materials, especially around ARIA symptoms and injection technique. Payers will be watching closely to see whether at-home dosing offsets costs elsewhere in the system. Earlier this week, several large practices reported they are preparing staff to transition patients to the new formulation. In the end, it is not a new drug, but it is a practical change that could make a big difference for patients and caregivers.
Image: PD
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