India Approves Eli Lilly's Alzheimer's Drug Donanemab

The Indian drug regulator has granted marketing approval for Eli Lilly's donanemab, a novel drug for Alzheimer's disease, sold as Kinsula. This approval marks a crucial step in offering advanced treatment options within India, targeting the underlying pathology of the disease by removing amyloid beta protein plaques in the brain. The drug is expected to be launched in the country in 2026.

Donanemab, a monoclonal antibody, is administered via intravenous infusion and has demonstrated the ability to slow cognitive decline in early-stage Alzheimer's patients. Clinical studies indicate a significant reduction in cognitive deterioration over a 76-week period, offering patients and their families more time and improved quality of life. The treatment is intended for individuals with mild cognitive impairment and mild dementia.

While the drug offers substantial benefits, potential adverse effects like amyloid-related imaging abnormalities (ARIA), including brain swelling and bleeding, have been noted in clinical trials. The cost also remains a consideration, with estimates suggesting a significant annual expense for patients. The final pricing for India is yet to be determined.