• 19 Nov 2025
• Admin
• News Article

Donanemab Gets CDSCO Approval in India: A Major Step Forward for Early Alzheimer’s Treatment

India now has a new weapon against Alzheimer’s disease. Eli Lilly has received CDSCO marketing authorization for donanemab, a disease-modifying therapy for adults in the early symptomatic stages of Alzheimer’s disease. This includes people with mild cognitive impairment (MCI) and those in the mild dementia stage, as long as amyloid pathology is confirmed.

This approval matters. India’s aging population is growing fast, and Alzheimer’s cases will rise sharply over the next decade.

Why Donanemab Matters?

Alzheimer’s is driven partly by amyloid plaques, which form when amyloid proteins clump together in the brain. These plaques can damage memory, thinking, planning, and daily functioning.

Donanemab helps the body remove excessive amyloid buildup. This slows cognitive and functional decline, giving patients more time to handle daily activities such as:

• Managing new information
• Remembering dates and appointments
• Planning and organizing
• Managing finances
• Using household appliances
• Staying independent for longer

What Lilly Says About the Approval?

Lilly India called this a major milestone for patients and caregivers.

Their message is clear:

• Donanemab directly targets amyloid plaques.
• The goal is to slow decline and extend quality of life.
• Lilly plans to expand access to innovative treatments for Indian patients.

India’s Alzheimer’s Challenge

Alzheimer’s disease accounts for 60–70% of all dementia cases worldwide.

India faces a growing burden:

• Millions remain undiagnosed because symptoms are subtle in early stages.
• By 2030, over 8 million Indians may live with dementia.
• Alzheimer’s will represent the largest share of these cases.
• Families and caregivers carry significant emotional and financial load.

Early diagnosis and timely treatment can make a meaningful difference.

What Patients Should Know About Donanemab?

Donanemab is approved for people with early symptomatic Alzheimer’s with confirmed amyloid pathology.

Treatment details:

• Delivered as an intravenous infusion every four weeks
• 700 mg for the first three doses, then 1400 mg thereafter
• Works by reducing amyloid plaques in the brain

Important safety considerations:

• Donanemab can cause amyloid-related imaging abnormalities (ARIA)
• Infusion-related reactions are possible
• Treatment requires monitoring by specialists

Lilly’s Broader Mission

Lilly has been developing medicines for nearly 150 years. Its treatments reach tens of millions of people worldwide, and donanemab adds to its growing neuroscience portfolio.

The Bottom Line

India now has access to a scientifically advanced therapy that targets Alzheimer’s at its earliest visible stage. For patients and caregivers, this decision offers something rare in Alzheimer’s care: slowed decline and more time.