Eisai and Biogen have received FDA approval for LEQEMBI IQLIK (lecanemab-irmb), a new autoinjector for maintaining treatment in early Alzheimer’s disease. This device delivers a 360 mg dose under the skin in just 15 seconds and will be available in the U.S. starting October 6, 2025. LEQEMBI IQLIK is designed for patients with mild memory problems or early dementia caused by Alzheimer’s. After 18 months of initial IV treatment, patients can continue with monthly IV infusions or switch to a weekly self-injection at home. The approval is based on additional studies from the Clarity AD trial, which showed that switching to the autoinjector after 18 months of IV treatment keeps the same benefits as continuing IV therapy. Over 600 patients were studied, and no serious side effects from the injections were reported. Systemic reactions (like allergic responses) were much rarer with the autoinjector—less than 1% compared to about 26% with IV infusions. The risk of brain swelling (ARIA), a known side effect of LEQEMBI, was similar between the autoinjector and IV treatments. Most ARIA cases happen within the first six months of IV treatment. LEQEMBI works by targeting harmful amyloid plaques in the brain. The companies state that this new option allows patients to keep slowing Alzheimer’s progression with either weekly self-injections or monthly IV treatments. In earlier trials, LEQEMBI slowed cognitive decline by 1.75 points over four years compared to a standard group and by 2.17 points compared to another study group.