Leqembi IQLIK targets amyloid plaques and protofibrils, which are thought to contribute to downstream tau accumulation.

The US Food and Drug Administration has approved Leqembi IQLIK as a subcutaneous injection for maintenance dosing in patients with early Alzheimer’s disease, defined as mild cognitive impairment or mild dementia. The autoinjector, administered weekly at 360 mg, will be available beginning October 6, 2025. Patients who complete 18 months of intravenous lecanemab at 10 mg/kg every 2 weeks may either transition to subcutaneous dosing or continue intravenous infusions once every 4 weeks.

Alzheimer’s disease is characterized by progressive cognitive decline associated with amyloid-beta and tau pathology. Clinical data indicate that discontinuation of therapy leads to biomarker re-accumulation and a return to placebo-level decline, suggesting the importance of continued maintenance treatment.

According to the company, the subcutaneous formulation may reduce reliance on infusion centers, decrease nursing and monitoring requirements, and improve patient convenience compared with intravenous therapy.

Eisai is responsible for the clinical development, regulatory submissions, and commercialization of lecanemab, which is approved in 48 countries with regulatory reviews ongoing in 10 additional markets. Ongoing trials include AHEAD 3-45 in preclinical Alzheimer’s disease and Tau NexGen in inherited forms of Alzheimer’s disease.

Source: BIoArtic AB