Leqembi Alzheimer’s drug approvals

In July 2026 the U.S. Food and Drug Administration cleared a subcutaneous, at‑home starter dose of Leqembi (lecanemab), allowing patients or caregivers to administer the first injection outside a clinic. The approval was based on data showing bioequivalence to the intravenous regimen and was expected to improve access in the United States.

A few weeks later, in early August 2026, Japan’s Eisai obtained marketing authorisation from India’s Central Drugs Standard Control Organisation and launched Leqembi as the country’s first disease‑modifying therapy for early‑stage Alzheimer’s disease. The Indian rollout highlighted the drug’s potential to slow cognitive decline, while also noting challenges such as early diagnosis, biomarker testing, infusion infrastructure and reimbursement.

Together, the two events illustrate the expanding regulatory rollout of Leqembi across major markets, moving from a new at‑home dosing option in the United States to its first introduction as a disease‑modifying treatment in India.