FDA has approved Eisai and Biogen’s Leqembi iqlik, a once-weekly 360 mg subcutaneous autoinjector for maintenance dosing after 18 months of intravenous lecanemab in early Alzheimer’s disease. The device delivers 1.8 mL in approximately 15 seconds and is set to launch in the U.S. on October 6, 2025. Patients who complete the 18‑month initiation phase on 10 mg/kg IV every two weeks can either transition to the weekly SC autoinjector or remain on IV maintenance at 10 mg/kg every four weeks.
This is more than a formulation tweak; it is a strategic repositioning of anti-amyloid therapy from an infusion-dependent model toward at-home chronic maintenance. Convenience and capacity release could meaningfully shift the adoption curve, but only if commercial and medical teams solve a new set of operational realities: benefit design, monitoring, adherence, and site-of-care economics.
The approval rests on sub-studies from the Clarity AD open-label extension, showing that switching to weekly subcutaneous maintenance preserved clinical and biomarker benefits comparable to continued IV maintenance. Across studied SC doses, injection-site reactions were generally mild, and systemic reactions were less frequent than with infusions. At the same time, ARIA rates on the weekly 360 mg regimen were comparable to those seen with ongoing IV dosing. Human factors and device tolerability work suggest patients and care partners can manage injections at home, potentially easing the burden of repeated clinic visits.
For patients and caregivers, the value proposition is clear: after a resource-intensive initiation phase, maintenance can be moved out of infusion suites, thereby shrinking treatment time and logistics. For health systems, subcutaneous maintenance could free infusion capacity for new starts, a critical constraint in a therapy area that requires imaging, genotype-informed risk discussions, and structured monitoring. For neurology practices, the shift demands new workflows for training, remote follow-up, and persistence tracking. For payers, the pivotal question is benefit alignment: IV maintenance typically falls under the medical benefit, while an at‑home autoinjector often migrates to the pharmacy benefit. That shift could change cost-sharing for Medicare beneficiaries and alter prior authorization criteria. Eisai’s hub services and patient assistance may buffer friction, but coverage policy clarity will be decisive for 2026 plan designs.
Competitionally, the move raises the bar in a class where convenience and total cost of care matter as much as efficacy deltas. If Lilly’s donanemab remains predominantly IV in maintenance, Leqembi’s at‑home option could become a tie‑breaker for physicians and families balancing clinic capacity and caregiver burden. Conversely, the weekly cadence—while fast to administer—creates a different adherence challenge than monthly infusions, putting a premium on digital support, pharmacy coordination, and real-world evidence that persistence translates into sustained clinical benefit outside controlled settings.
More broadly, Leqembi iqlik highlights a cross-therapeutic trend: transitioning high-cost biologics to home administration to unlock capacity, reduce administration costs, and expand reach. Provided safety monitoring can be maintained and reimbursement pathways are aligned. Medical Affairs will need to codify transition protocols from IV to SC, optimize MRI monitoring schedules, and generate post-approval RWE to confirm comparable outcomes and safety by APOE genotype and comorbidity. Market access teams should prepare for mixed-benefit contracting, site‑of‑care steering, and outcomes-based constructs tied to treatment continuity.
The next six months will reveal whether at‑home maintenance becomes the default in early Alzheimer’s or stalls on the shoals of benefit design and monitoring logistics. Will payers embrace the capacity and cost-offset narrative and position weekly SC as preferred maintenance, and will rivals answer with their own at‑home strategies—or will infusion-based status quo hold in neurology’s first actual disease-modifying class?
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
