US-based pharma giant Eli Lilly has launched its Alzheimer’s drug donanemab in India under the brand name Lormalzi, marking the country’s first approved amyloid plaque-targeting therapy for patients with early-stage Alzheimer’s disease.
The drug will cost Rs 91,688 per vial.
The launch comes at a time when a growing scientific debate has raised questions over whether this class of drugs offers meaningful clinical benefits despite reducing amyloid buildup in the brain.
The company announced on Wednesday that the Central Drugs Standard Control Organization (CDSCO) had authorised Lormalzi for treating patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease.
The drug is administered as a once-monthly intravenous infusion and is designed to remove amyloid plaques, protein deposits widely associated with the disease.
Eli Lilly said the launch reflects its long-term commitment to Alzheimer’s care in India, where dementia cases are rising rapidly with an ageing population. According to the company, dementia affects around 8.8 million people in India currently, with Alzheimer’s accounting for the majority of cases.
The number is expected to nearly double by 2036.
“For 35 years, Lilly has been a global pioneer advancing research of therapies and diagnostics for people with Alzheimer’s disease,” said Winselow Tucker, president and general Manager of Eli Lilly India. He added that Alzheimer’s imposes a major emotional and economic burden on patients, caregivers and healthcare systems.
RISING DISEASE BURDEN
Alzheimer’s disease is the most common cause of dementia, a progressive neurological condition that impairs memory, thinking and daily functioning.
India’s dementia burden is projected to grow sharply as life expectancy rises and awareness remains limited.
Globally, more than 55 million people are estimated to be living with dementia, and that figure is expected to triple by 2050.
In India, dementia is estimated to cost the economy over 28,300 crore annually through healthcare expenses and caregiving demands.
Lilly argues that earlier diagnosis and treatment could improve quality of life and potentially reduce long-term care costs.
The company also said delayed progression of dementia by even two years could significantly reduce caregiving needs.
The launch places India among a small group of countries where anti-amyloid therapies are commercially available. Donanemab had earlier received regulatory approval in the US and some other markets after clinical trials showed it slowed cognitive decline in some patients with early Alzheimer’s disease.
QUESTIONS OVER EFFECTIVENESS
However, the arrival of the drug coincides with mounting scrutiny over anti-amyloid therapies as a class. A major Cochrane review published last month concluded that drugs targeting amyloid-beta proteins, including donanemab and lecanemab, produced “absent or trivial” clinical benefits despite successfully clearing amyloid plaques from the brain.
The review analysed data from 17 clinical trials involving more than 20,000 participants with mild cognitive impairment or early Alzheimer’s dementia.
Researchers found that the drugs did not lead to clinically meaningful improvements in cognition or daily functioning and raised the risk of brain swelling and bleeding.
“Unfortunately, the evidence suggests that these drugs make no meaningful difference to patients,” lead author Francesco Nonino had said in the review. The researchers also questioned whether reducing amyloid plaques translates into real-world benefits for patients.
The findings have sparked a sharp debate within the scientific community.
Some Alzheimer’s researchers and advocacy groups argue that the review unfairly combined older failed drugs with newer therapies such as donanemab, which they say have demonstrated modest but measurable slowing of disease progression.
Experts note that patients receiving anti-amyloid therapies often require regular MRI scans to monitor for amyloid-related imaging abnormalities (ARIA), a potentially serious side effect involving brain swelling or bleeding.
Despite the controversy, the approval of donanemab in India signals a new phase in Alzheimer’s treatment in the country, where therapeutic options have largely been limited to medicines that temporarily manage symptoms rather than alter disease progression.
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