By Fineline Cube 
Japan-based Eisai (TYO: 4523) and US-based Biogen (NASDAQ: BIIB) announced that the U.S. Food and Drug Administration (FDA) has granted approval for the subcutaneous auto‑injector formulation of lecanemab (brand name LEQEMB), sold under the product name IQLIK. The device is cleared for maintenance therapy in early Alzheimer’s disease (AD) and is set to launch in the United States on October 6 2025.
Why IQLIK Matters
- First‑in‑class home delivery – The 360 mg/1.8 mL (200 mg/mL) dose can be administered in ~15 seconds, eliminating the need for frequent clinic visits.
- Comparable efficacy – Data from the Clarity AD trial and its open‑label extension demonstrate that the subcutaneous (SC‑AI) route matches the intravenous (IV) formulation in both clinical outcomes and biomarker reduction.
- Safety advantage – Systemic reaction rates fall below 1 % with SC delivery versus 26 % with IV infusions, a substantial reduction in infusion‑related events.
How Lecanemab Works
Lecanemab is a monoclonal antibody that selectively binds amyloid‑beta (Aβ) proto‑fibrils, promoting clearance of neurotoxic plaques and slowing disease progression in patients with mild cognitive impairment or mild dementia.
Market Implications
- Patient convenience – Home‑based dosing empowers patients and caregivers, potentially improving adherence and reducing healthcare costs.
- Competitive edge – The FDA approval positions Eisai‑Biogen at the forefront of AD therapeutics, offering a differentiated product in a rapidly expanding market.
- Future pipeline – The success of IQLIK may accelerate the development of additional subcutaneous biologics for neurodegenerative disorders.-Fineline Info & Tech