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NEW DELHI — In a major breakthrough for neurological medicine in South Asia, India’s primary drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has granted marketing authorisation to Leqembi (lecanemab). Developed jointly by Japanese pharmaceutical firm Eisai and US-based Biogen, the intravenous therapy becomes the first disease-modifying drug approved in India capable of slowing the biological progression of early Alzheimer’s disease.
For decades, clinicians treating dementia in India could offer only symptomatic treatments—medications that temporarily bolster neurotransmitters without altering the underlying destruction of brain tissue. The CDSCO approval signals a fundamental shift toward biological intervention, offering renewed hope to an aging nation facing an unprecedented dementia burden.
Modifying the Disease: How Leqembi Operates
Alzheimer’s disease is pathologically characterized by the abnormal buildup of amyloid-beta, a protein that clusters into toxic, sticky plaques between neurons, eventually disrupting communication and triggering neuronal death.
Leqembi is a humanized monoclonal antibody designed to attach specifically to soluble and insoluble aggregated forms of amyloid-beta. By binding to these protein clumps, it prompts the brain’s immune cells (microglia) to clear the toxic deposits.
Unlike historic options that simply mask cognitive decline, Leqembi targets the root pathology of early-stage disease.
Administration Profile:
The Clinical Evidence: Trial Results and Cognitive Outcomes
The CDSCO’s decision is anchored in data from Clarity AD, a pivotal Phase 3 global clinical trial evaluating 1,795 participants aged 50 to 90 with early-stage Alzheimer’s disease.
| Metric / Endpoint | Placebo Group | Leqembi Group | Primary Outcome |
| CDR-SB Score Change (18 Months) | Baseline deterioration | 27% slower rate of decline | $p < 0.0001$ (Statistically Significant) |
| Absolute Score Difference | Standard progression | −0.45 points vs. placebo | $95\%\text{ CI: } [-0.67, -0.23]$ |
| Amyloid Plaque Burden | Unchanged/Increased | Marked reduction | Reached normal levels in majority |
Beyond the primary endpoint, key secondary measures—including the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog14) and activities of daily living scales—showed consistent benefits. Multi-year observational data presented in 2025 further indicate that therapeutic gains may persist over extended treatment periods.
Navigating Safety Risks: Monitoring for ARIA
While representing a significant scientific advance, Leqembi requires rigorous safety oversight. The primary clinical safety concern associated with amyloid-clearing monoclonal antibodies is Amyloid-Related Imaging Abnormalities (ARIA).
ARIA primarily manifests in two forms:
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ARIA-E: Brain edema or swelling.
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ARIA-H: Microhemorrhages (small brain bleeds) and superficial siderosis.
Though most ARIA cases are asymptomatic and resolve with temporary treatment pause, severe or life-threatening brain edema can occur. Patients carrying the APOE4 gene—especially homozygotes—face an elevated risk of developing ARIA.
Baseline MRI Scan ---> Infusion Schedule Begins ---> Safety MRI Monitoring
(Rule out bleeds) (Biweekly 1-Hour IVs) (Prior to Doses 5, 7, 14)
international guidelines from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) mandate regular magnetic resonance imaging (MRI) monitoring during the first year of therapy. Neurologists must watch closely for symptoms such as persistent headaches, sudden confusion, visual disturbances, dizziness, or gait impairment.
Access, Diagnostics, and Economic Reality in India
Japanese manufacturer Eisai announced the commercial availability of Leqembi in India, pricing the drug at approximately ₹21,682 per vial. Total annual therapy costs will depend on patient weight and specific dosing requirements, placing it firmly in the premium specialty medicine tier.
Crucially, the therapy is not suitable for every individual experiencing memory loss.
[ Patient Presents with Cognitive Decline ]
│
▼
[ Neuropsychological Assessment ]
│
▼
[ Confirmed Early Alzheimer's / MCI ]
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┌─────────────────────────────────────────────────┐
│ Biomarker Verification (Amyloid Positivity) │
│ • CSF Amyloid Analysis │
│ • Amyloid PET Imaging │
│ • High-Accuracy Blood Biomarkers (p-tau217) │
└─────────────────────────────────────────────────┘
│
▼
[ Initiate Leqembi Infusion Protocol ]
Key Obstacles to Nationwide Scale
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Diagnostic Bottlenecks: Advanced PET scanners and specialized CSF diagnostic facilities remain largely concentrated in tier-1 urban medical centers.
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Infusion Infrastructure: Biweekly hospital-based infusions demand dedicated day-care facility arrangements and trained nursing staff.
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Out-of-Pocket Expense: Without broad insurance coverage or public health subsidies, treatment costs present a substantial barrier for average households.
Expert Perspectives and Limitations
Independent medical experts urge balanced expectations regarding what the drug can accomplish.
“It is critical to clarify that Leqembi is not a cure,” emphasizes a senior consultant neurologist not affiliated with the trial research. “A 27% slowing of cognitive decline is medically significant on a population scale—it buys patients time. However, it does not restore lost memories or reverse structural damage that has already occurred.”
Some health economists point out an ongoing academic debate surrounding the Minimal Clinically Important Difference (MCID) on the CDR-SB scale. While the trial demonstrated a clear statistically significant reduction of 0.45 points, some researchers argue that an absolute change between 0.98 and 1.63 points is typically required for a patient or caregiver to notice a day-to-day functional change.
Public Health Implications for South Asia
With an estimated 4 to 5 million individuals living with dementia across India—a figure projected to double by 2050 due to an aging population—the arrival of disease-modifying therapies represents both an opportunity and a wake-up call for public health planners.
Health policy specialists suggest national health strategies must now focus on:
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Expanding Biomarker Infrastructure: Standardizing high-accuracy blood tests (such as p-tau217) to reduce reliance on costly PET scans.
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Primary Care Training: Training general practitioners to identify early cognitive impairment before the disease advances beyond the therapeutic window.
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Safety Monitoring Networks: Establishing specialized neurological infusion hubs capable of managing potential ARIA events safely.
The Path Forward
The approval of Leqembi opens a new chapter in India’s management of neurodegenerative disorders. While financial and diagnostic access hurdles remain steep, the entry of disease-modifying options will likely catalyze local investment in dementia screening, specialized clinical protocols, and biomarker research.
Patients and family members suspecting early memory loss are advised to consult a board-certified neurologist or memory clinic to evaluate whether biomarker screening and early intervention are appropriate.
Medical Disclaimer: This article is for informational purposes only and should not be considered medical advice. Always consult with qualified healthcare professionals before making any health-related decisions or changes to your treatment plan. The information presented here is based on current research and expert opinions, which may evolve as new evidence emerges.
References
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Business Standard. “Eisai launches Alzheimer’s drug Leqembi in India after CDSCO approval.” August 4, 2026. https://www.business-standard.com/industry/news/eisai-launches-leqembi-alzheimers-drug-india-after-cdsco-approval-126080400475_1.html
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