Eli Lilly’s Donanemab receives CDSCO nod for treatment of early symptomatic Alzheimer’s Disease

Eli Lilly and Company (India) has announced that the Central Drugs Standard Control Organization (CDSCO) has granted marketing authorisation for donanemab (350 mg/20 mL administered every four weeks via intravenous infusion as described in the prescribing information) for the treatment of Alzheimer’s disease (AD) in adults with early symptomatic stages.

This includes individuals with mild cognitive impairment (MCI) and those in the mild dementia stage of AD, with confirmed amyloid pathology.

Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with Alzheimer’s disease. Donanemab is a disease modifying drug that helps the body remove excessive buildup of amyloid plaques and slows the cognitive and functional decline that may diminish people’s ability to remember new information, important dates, and appointments; plan and organize; make meals; use household appliances; manage finances; and be left alone.

Alzheimer’s disease is the most common cause of dementia globally, accounting for 60–70% of cases. However, currently, it is highly underdiagnosed. India, with its rapidly ageing population, faces a growing health challenge: it is estimated that by 2030, over 8 million people in India will be living with dementia, with Alzheimer’s disease representing the largest share of cases. Early diagnosis and treatment are critical to improving patient outcomes and easing the significant burden on families and caregivers.