Eisai launches Alzheimer's drug Leqembi in India after CDSCO approval

Japanese drugmaker Eisai has launched Leqembi (lecanemab) in India following approval from the Central Drugs Standard Control Organisation (CDSCO), becoming one of the first companies to introduce a disease-modifying therapy for patients with early Alzheimer’s disease in the country.

The therapy is indicated for patients with mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease. It is designed to target the underlying biology of the disease rather than provide only symptomatic relief.

The launch comes at a time when India’s dementia burden is rising rapidly. According to the AIIMS-USC Longitudinal Ageing Study in India (LASI), around 8.8 million Indians aged 60 years and above were living with dementia in 2023, with the number expected to nearly double by 2036.


Leqembi is administered through intravenous infusion and works by clearing amyloid-beta plaques in the brain while preventing the formation of new plaques, one of the hallmarks of Alzheimer’s disease. Patients must undergo biomarker testing to confirm amyloid pathology before becoming eligible for treatment.

“The therapy has demonstrated a slowing of cognitive decline, which is a clinically meaningful benefit for patients. It is designed to address the underlying disease process and help preserve cognitive function for a longer duration compared to the natural progression of the disease,” the company said.

The treatment will be priced on a weight-based dosing schedule, with a maximum retail price of Rs 21,682 per vial. Total treatment costs will vary depending on a patient’s body weight and dosing requirements.

Eisai said Indian patients were not included in the pivotal Phase III clinical trial that supported the drug’s approval. The global study enrolled more than 800 patients. As part of the Indian regulatory approval, the company will conduct a Phase IV post-marketing study to generate efficacy and safety data in Indian patients.

“What is promising about Leqembi is its ability to intervene early in the disease process. Identifying the right patient at the right time will be critical to maximising outcomes,” said Ritesh Jain, head of commercial operations at Eisai India.

The launch comes about a month after Eli Lilly introduced Lormalzi (donanemab) in India, intensifying competition in the country’s nascent market for disease-modifying Alzheimer’s therapies.

Despite the availability of new therapies, adoption is expected to remain gradual because of challenges including delayed diagnosis, limited availability of biomarker testing, infusion infrastructure requirements and the absence of widespread reimbursement.

“Access and awareness remain critical barriers in Alzheimer’s disease care in India. Our support programmes are aimed at helping eligible patients initiate and continue therapy,” said Takuya Kijima, managing director of Eisai India.

Leqembi has already received regulatory approvals in more than 50 countries and regions, including the United States, Japan, Europe and China.