The U.S. Food and Drug Administration has approved the first at-home treatment for early-stage Alzheimer's disease, in a move aimed at making it easier for patients to access treatment and reducing the need to receive it within medical facilities.
On Monday, the FDA announced its approval of the injectable form of the drug lecanemab, marketed under the brand name Leqembi Iqlik, making it the first Alzheimer's treatment that can be started at home without the need for intravenous infusion in a hospital or clinic. (Intravenous infusion means administering the drug by introducing it directly into the bloodstream through a vein using a small needle connected to a tube, so that the drug reaches the body gradually over a specific period of time.)
The U.S. Food and Drug Administration (FDA) first approved the drug in July 2023, but its use was then limited to biweekly intravenous infusions in medical facilities. In August 2025, it approved subcutaneous injections for maintenance doses for patients who had completed 18 months of intravenous therapy. The new approval allows patients to begin treatment immediately with home injections, either on their own or with the assistance of a healthcare provider
Lekanimab works by targeting amyloid-beta protein, which accumulates in the brains of Alzheimer's patients, forming plaques associated with nerve cell damage, particularly in areas responsible for memory and cognitive functions. The drug binds to the protein before it forms plaques, then stimulates immune cells in the brain to clear it, thus helping to reduce its accumulation and slow cognitive decline.
The new treatment will be given in two weekly doses of 250 mg each during the first months of treatment, before moving to a weekly maintenance dose of 260 mg
The U.S. Food and Drug Administration confirmed that the new approval represents the first time patients can begin treatment at home, which is expected to ease the burden on patients and their families and increase access to treatment.
The approval came after new results were presented at the Alzheimer's Association International Conference, showing that weekly injections of a total dose of 500 mg achieve similar effectiveness to intravenous therapy in removing amyloid-beta protein and slowing disease progression.
A study presented at the Alzheimer's Clinical Trials Conference in December 2025 showed that long-term treatment with licanimab may delay the progression of mild cognitive impairment, a precursor to dementia, to Alzheimer's disease for up to 8.3 years. However, this result was recorded in patients who started treatment early and had low levels of amyloid protein in the brain.
Isobel Coleman, chief executive of the Alzheimer's Drug Discovery Foundation, said the approval represents a turning point in the treatment of the disease, because the ease of administering the treatment will allow for the development of more flexible treatment strategies, in which therapies can be modified and combined according to the progression of each patient's condition.
The manufacturer has not yet specified a release date or price for the new version. Intravenous therapy costs approximately $26,500 annually, with health insurance programs, including Medicare, covering the majority of the cost.
The U.S. Food and Drug Administration explained that the injectable version has not undergone extensive independent clinical trials, but the approval was based on the results of two clinical studies that proved the safety and effectiveness of intravenous therapy, in addition to data that proved the equivalence of subcutaneous injection with it.
The FDA noted that the most common side effects include headaches, injection site reactions, and amyloid-associated imaging abnormalities (ARIA), which are changes in brain scans that may cause swelling or minor bleeding. In most cases, these changes disappear over time, but in rare instances, they can lead to serious complications such as cerebral edema or seizures.
Because the risk of developing these complications increases in carriers of the APOE e4 gene variant, which is associated with a higher likelihood of developing Alzheimer's disease, the U.S. Food and Drug Administration recommends genetic testing before starting treatment.
