FDA Approval of Leqembi Subcutaneous Formulation Charts Path to Combination Therapies for Alzheimer’s Disease

The U.S. Food and Drug Administration (FDA) today announced its approval of a subcutaneous formulation of Leqembi (lecanemab), branded as Leqembi Iqlik, for weekly maintenance dosing following the 18-month IV initiation phase. This is a major advancement that opens the door for faster and simpler drug delivery and paves the way for combination therapies – the same strategy that revolutionized cancer care.

"This shift to subcutaneous maintenance dosing is a crucial step toward making Leqembi more accessible for patients, similar to how diabetes and GLP-1 medications are delivered, and represents the first step towards the day when patients can bypass infusions altogether," said Dr. Howard Fillit, Co-Founder and Chief Science Officer at the ADDF. “This milestone lessens the burden on patients and caregivers by reducing the logistical challenges of receiving Alzheimer’s treatment, while also bringing us closer to the day when patients can more easily receive a combination of drugs, potentially administered from home."

Subcutaneous delivery means the drug can be injected just under the skin using an autoinjector once a week – taking only about 15 seconds – rather than requiring hour-long intravenous infusions in hospitals or infusion sites. While this administration method is currently only approved for maintenance dosing, Eisai and Biogen plan to file another application next week for subcutaneous dosing without the need for an IV initiation phase. As more Alzheimer’s treatments progress through development and gain approval, subcutaneous formulations will likely become increasingly common.

Beyond convenience, this delivery innovation removes a critical barrier to combination therapies. With a more practical and scalable approach to drug administration, physicians will be better positioned to incorporate additional therapies that target the full spectrum of aging biology. This is especially timely as more than 70% of the current Alzheimer's drug pipeline focuses on non-amyloid pathways.

"We’ve long known that Alzheimer’s is not a one-target disease, and the future lies in precision combination therapies tailored to each patient based on their individual biomarker profiles," Dr. Fillit said. "Subcutaneous delivery is more than an upgrade – it’s a gateway to the next generation of Alzheimer’s care, accelerating our ability to bring effective, multi-modal treatment regimens to the millions of patients who need them."