Written by Anonna DuttNovember 18, 2025 08:18 PM IST 4 min readThe drug is administered as an intravenous infusion every four weeks in people with mild cognitive impairment and mild dementia.The Indian drug regulator has given a nod to pharmaceutical giant Eli Lilly for marketing its latest Alzheimer’s drug donanemab — sold as Kinsula — in the country. This is one of only three new class of drugs that has been approved globally for the treatment of the neuro-degenrative disease. The drugs work by clearing out plaques of amyloid beta protein — an unusual deposition of the protein in the brain that is a hallmark of Alzheimer’s.The medicine is likely to be launched in the country in 2026, according to the company. Winselow Tucker, president and general manager, Lilly India, in a press statement said: “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. By offering an innovative therapy that targets amyloid plaques and slows cognitive decline, we aim to give patients and their families more time and a better quality of life.”The nod from the Indian drug regulator comes just over a year after the United States’ drug regulator granted approval to the drug — after it initially set up a special committee of experts to review its safety and efficacy following irregularities in approval of previous drugs from the same class of medicines.What do we know about donanemab?Donanemab is essentially a monoclonal antibody that attacks the amyloid beta protein plaques in the brain and has been shown to slow cognitive decline in patients with early stages of Alzheimer’s disease. The drug is administered as an intravenous infusion every four weeks in people with mild cognitive impairment and mild dementia.Patients are given 700 mg of the drug for the first three times followed by 1400 mg thereafter.The phase III study shows that donanemab slows down the cognitive decline in early Alzheimer’s patients by 35.1 per cent at 76 weeks. The result was based on a study with 1,736 patients, of whom 860 received the infusion every four weeks till the amyloid beta plaque clears.Are there any adverse effects?The main adverse effect of the drug is called amyloid-related imaging abnormalities (ARIA), which shows up as temporary swelling in areas of the brain that usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain.Story continues below this adThis usually does not have any symptoms, but serious and life-threatening events can occur in rare instances. The study mentioned above showed that 24% participants given donanemab had brain swelling and 19.7% had brain bleeds. There were also three treatment related deaths reported in the study.Why is this important?The availability of the drug is significant considering an aging population in the country, which will be at an increased risk of neurodegenerative diseases including Alzheimer’s. The number of Indians over the age of 60 is likely to increase from 103 million in 2011 to 319 million in 2050. An estimated 5.3 million people are currently living with dementia in India and Alzheimer’s is one of the most common forms of dementia. This prevalence is likely to increase to 14 million by 2050.The challenge with the new drugs remains the cost. The drug is estimated to cost Rs 32,000 a year for a person of average weight in the United States. “The pricing of donanemab for India has yet not been finalised,” the company said.Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government’s management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Dutt also takes a keen interest in the country’s space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University’s Dart Centre. Dutt has a Bachelor’s Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times. When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More© The Indian Express Pvt LtdTags:Alzheimer's