India Approves Donanemab for Early Alzheimer’s as Lilly Targets 2026 Launch

Overview

• CDSCO granted marketing authorisation for donanemab, an amyloid-targeting monoclonal antibody for adults with mild cognitive impairment and mild dementia due to Alzheimer’s.
• The therapy is administered by intravenous infusion every four weeks, with the Indian approval covering a 350 mg/20 mL presentation.
• Eli Lilly says it plans to introduce the drug in India in 2026, with no pre-approval local safety or efficacy studies conducted.
• Post-marketing surveillance and a Phase IV study are planned in India, as clinicians flag risks such as amyloid-related imaging abnormalities and the need for MRI monitoring.
• Indian pricing has not been announced, and reports cite a U.S. list price near $32,000 per year as experts warn early access may be concentrated in major urban centres.