In recent years, there have been significant advancements in the treatment of Alzheimer’s disease, a condition that affects millions worldwide. Two drugs, in particular, have made headlines: lecanemab (Leqembi) and donanemab (Kisunla). Here’s what you need to know about these new FDA-approved treatments.
### Lecanemab (Leqembi)
Lecanemab is an amyloid beta-directed monoclonal antibody, which means it targets the amyloid plaques in the brain that are associated with Alzheimer’s disease. It was approved by the FDA in 2023 and has been making waves in the medical community. This drug is administered intravenously and has shown promise in slowing down cognitive decline in early stages of Alzheimer’s.
In January 2025, the FDA approved a supplemental application for lecanemab, allowing for a maintenance dosing regimen. This means that after an initial phase of dosing every two weeks, patients can transition to receiving the drug once every four weeks. Additionally, a subcutaneous autoinjector version is under review, which could make administration easier for patients.
### Donanemab (Kisunla)
Donanemab was approved by the FDA in July 2024 and also targets amyloid plaques. It is another significant addition to the arsenal against Alzheimer’s, offering hope for those in the early stages of the disease. While specific details about its dosing regimen and administration method are not as widely discussed as lecanemab, it represents a crucial step forward in treating Alzheimer’s.
### Other Developments
Beyond these FDA-approved drugs, there are other promising treatments on the horizon. For instance, Axsome Therapeutics is working on AXS-05, a drug aimed at treating agitation associated with Alzheimer’s disease. This condition is a common challenge for caregivers and patients alike, and having a dedicated treatment could greatly improve quality of life. AXS-05 has shown significant efficacy in clinical trials and is expected to be submitted for FDA approval in the spring or summer of 2025.
Another notable development is Hydromethylthionine Mesylate (HMTM) from TauRx Pharmaceuticals. Unlike most current treatments that focus on amyloid, HMTM targets tau protein, another key component in Alzheimer’s pathology. It has demonstrated sustained benefits in slowing cognitive decline and is being considered for regulatory approval in several countries.
These advancements signal a new era in Alzheimer’s treatment, offering more options and hope for patients and their families. As research continues to evolve, we can expect even more innovative therapies to emerge, potentially changing the landscape of dementia care forever.
