Eli Lilly and Company (India) Pvt. Ltd. has received marketing authorization from the Central Drugs Standard Control Organization (CDSCO) for donanemab (350 mg/20 mL, administered every four weeks via intravenous infusion as per prescribing information) for the treatment of Alzheimer’s disease (AD) in adults in the early symptomatic stages. This includes individuals with mild cognitive impairment (MCI) and those with mild dementia due to AD, with confirmed amyloid pathology.
Amyloid is a naturally occurring protein in the body that can accumulate and form amyloid plaques in the brain. Excessive buildup of these plaques is associated with the memory loss and cognitive decline characteristic of Alzheimer’s disease. Donanemab is a disease-modifying therapy that helps clear amyloid plaques, slowing both cognitive and functional deterioration. By reducing the rate of decline, the treatment aims to preserve abilities such as learning new information, remembering important dates, planning daily tasks, preparing meals, managing household appliances and finances, and maintaining independence for longer.
Alzheimer’s disease is the leading cause of dementia worldwide, responsible for 60–70% of cases, yet remains significantly underdiagnosed. With India’s rapidly aging population, the national burden is rising: by 2030, more than 8 million people in India are projected to be living with dementia, with Alzheimer’s disease accounting for the majority of cases. Early detection and timely treatment are essential to improving outcomes and reducing the burden on families and caregivers.
Donanemab is specifically indicated for individuals with MCI or mild dementia stage of early symptomatic Alzheimer’s disease who have confirmed amyloid pathology. The treatment may cause serious side effects, including amyloid-related imaging abnormalities (ARIA) and infusion-related reactions. It is administered intravenously every four weeks—700 mg for the initial three doses, followed by 1400 mg for subsequent doses.
Lilly is a global pharmaceutical company with nearly 150 years of scientific innovation. Its medicines serve tens of millions of people worldwide, reflecting its ongoing commitment to advancing treatments that improve lives.
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