 "Lilly's Donanemab gets CDSCO approval for early Alzheimer's treatment")
Eli Lilly and Company India on Tuesday received marketing authorisation from the Central Drugs Standard Control Organization (CDSCO) for donanemab, a treatment for adults in the early symptomatic stages of Alzheimer’s disease. The therapy is approved for individuals with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s, with confirmed amyloid pathology.
Donanemab, administered via intravenous infusion every four weeks, is designed to target and help clear amyloid plaques, abnormal protein deposits associated with memory loss and cognitive decline in Alzheimer’s patients. According to Lilly, the treatment has demonstrated an ability to slow both cognitive and functional deterioration, potentially helping patients maintain everyday skills for a longer duration.
“The approval of donanemab marks a significant milestone in our mission to address the urgent needs of people living with Alzheimer’s disease in India,” said Winselow Tucker, president and general manager, Lilly India. He said the therapy aims to provide patients and families “more time and a better quality of life,” adding that the approval reinforces the company’s broader focus on bringing advanced treatments to India.
Alzheimer’s disease is the leading cause of dementia globally, accounting for up to 70 per cent of cases. Despite its growing prevalence, especially in ageing populations such as India’s, it remains significantly underdiagnosed. By 2030, more than 8 million people in India are projected to be living with dementia, with Alzheimer’s representing the majority of cases, according to the Alzheimer’s and Related Disorders Society of India (ARDSI). Experts say early diagnosis and timely access to treatment are critical in managing the condition’s long-term impact on patients and caregivers.
Donanemab is an amyloid-targeting, disease-modifying therapy that will be prescribed for patients in early symptomatic stages of Alzheimer’s. Treatment begins with three doses of 700 mg, followed by subsequent doses of 1400 mg administered every four weeks. Lilly cautions that the drug may cause amyloid-related imaging abnormalities (ARIA) and infusion-related reactions, and must be administered under medical supervision.
Founded nearly 150 years ago, Lilly develops medicines across areas such as diabetes, obesity, Alzheimer’s, immune disorders and cancer. The company says it is working to expand access to innovative treatments and ensure clinical trials reflect global diversity.