Category: New Drug Approval | Alzheimer’s disease
Written and Reviewed By: Pharmacally Editorial Team
In a major step, the U.S. Food and Drug Administration (FDA) has approved LEQEMBI® IQLIK™ (lecanemab-irmb) as a subcutaneous injection for maintenance dosing in patients with early Alzheimer’s disease. Alzheimer’s disease is one of the most critical health issues affecting millions of older adults worldwide. Alzheimer’s disease has no cure but this recent advances in disease-modifying therapies have offered new hope. This new approval provides patients and caregivers with a more convenient alternative to traditional intravenous (IV) infusions. FDA approval was jointly granted to the Eisai–Biogen partnership as they co-developed and co-market LEQEMBI®, which now include the newly approved IQLIK™ subcutaneous formulation for maintenance dosing in early Alzheimer’s disease.
What Is Leqembi?
LEQEMBI (lecanemab-irmb) is a monoclonal antibody designed and developed to target and clear amyloid-beta. Amyloid-beta is a protein fragments that builds up abnormally in the brains of people with Alzheimer’s disease. These sticky builds up also called amyloid plaques are strongly linked to the memory loss and cognitive decline seen in the Alzheimer disease.
LEQEMBI was previously approved in 2023 as an IV infusion every two weeks. Now, with the FDA’s new approval, eligible patients can receive it through a subcutaneous injection (under the skin) which reduce the need for frequent infusions and cancer daycare center visits.
Why Subcutaneous Injection
The availability of a subcutaneous option is a significant expansion of the current therapy for patients and families. IV infusions can be time-consuming, requiring hospitals, daycare or clinic visits, and sometimes cause difficulties in long-term adherence of the treatment.
Advantage of LEQEMBI IQLIK
The treatment can be given in a short outpatient procedure.
It allows for maintenance dosing after initial IV induction therapy.
It can improve treatment accessibility, patient comfort and patient adherence, especially for older adults.
Clinical Evidence
The FDA’s decision and BLA was supported by LEQEMBI subcutaneous (SC) sub-studies of the Phase 3 Clarity AD open-label extension trial in individuals with early AD that evaluated the safety, effectiveness, and pharmacology of subcutaneous dosing compared with the IV form.
The sub-studies data shows that patient can shift to weekly LEQEMBI IQLIK autoinjector after 18 months of the initial intravenous dosing at 10 mg/kg every two weeks this dosing is able to maintain clinical and biomarker level benefits as compared to intravenous dosing.
Safety Profile: Safety of LEQEMBI IQLIK was studied on 600 patients, out of these 49 patients received weekly 360 mg subcutaneous maintenance dose after at least 18 months of 10 mg/kg IV every two week and no patient has developed any local or systemic injection-related adverse events (AEs). However safety profile is consistent with that of intravenous dosing except systemic reactions were much less common in subcutaneous dosing which is less than 1% compared to 26% with intravenous. 11% of patients experienced mild to moderate local reactions like redness, swelling, itching and injection site reactions. 1% patient developed mild reactions like headache, fever and fatigue.
As with other anti-amyloid therapies, the most notable risk is Amyloid-Related Imaging Abnormalities (ARIA), which can appear as brain swelling or microhemorrhages visible on MRI. Symptoms may include headache, confusion, dizziness, or visual changes. Most cases are mild or asymptomatic in subcutaneous group, but regular MRI monitoring remains an important part of therapy.
Public Health Impact
Alzheimer’s disease currently affects more than 6 million Americans, and that number is expected to rise as the population ages. The approval of LEQEMBI IQLIK expands treatment options and makes disease-modifying therapy more practical for day-to-day life.
Eisai has emphasized its commitment to making LEQEMBI available to patients who may benefit from it. In the United States, the company has introduced several support programs to ease the treatment journey for patients and their caregivers. Dedicated Patient Navigators will work closely with families to guide them through treatment steps, insurance coverage, and what to expect with co-pay and access programs.
For patients starting on the newly approved LEQEMBI IQLIK injection, additional support will be available to ensure safe and smooth use of the therapy. To reduce financial barriers, Eisai’s Patient Assistance Program (PAP) will provide LEQEMBI or LEQEMBI IQLIK at no cost to eligible uninsured or underinsured patients, including Medicare beneficiaries, who meet specific financial and medical criteria.
LEQEMBI IQLIK will be available in US from 06 October 2025.
Experts see this as an important step in reducing barriers to care. Easier administration could increase adoption and adherence; ultimately it can improve outcomes for patients at an early stage of disease when intervention is most beneficial.
Conclusion
The FDA approval of LEQEMBI IQLIK subcutaneous injection represents a milestone in Alzheimer’s care, giving patients a less invasive, more practical way to continue therapy. LEQEMBI IQLIK is newer addition to the disease-modifying strategies and offers renewed hope for patients and caregivers tackling early Alzheimer’s disease.
References
FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer’s Disease, Biogen, 29 August 2025, https://investors.biogen.com/news-releases/news-release-details/fda-approves-leqembir-iqliktm-lecanemab-irmb-subcutaneous
US FDA approves Leqembi® IQLIK ™ (lecanemab-irmb) subcutaneous injection for maintenance dosing for the treatment of early Alzheimer’s disease, Bioarctic, 29 August 2025, https://www.bioarctic.com/en/us-fda-approves-leqembi-iqlik-lecanemab-irmb-subcutaneous-injection-for-maintenance-dosing-for-the-treatment-of-early-alzheimers-disease/
FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer’s Disease, Eisai US, https://media-us.eisai.com/2025-08-29-FDA-Approves-LEQEMBI-R-IQLIK-TM-lecanemab-irmb-Subcutaneous-Injection-for-Maintenance-Dosing-for-the-Treatment-of-Early-Alzheimers-Disease
LEQEMBI (lecanemab-irmb) Prescribing Information. Nutley, NJ: Eisai Inc. https://www.leqembi.com/en/-/media/Files/Leqembi/Prescribing-Information.pdf?hash=5deab3d7-c731-44fc-8acc-2c49ee44822c&utm_source=digital&utm_medium=url_redirect&utm_campaign=yscb_wallet_card