Key facts
- Eli Lilly's Alzheimer's drug donanemab has been approved in India.
- The drug, known as Lormalzi in India, targets early-stage Alzheimer's disease.
- Neurologists have flagged concerns regarding the drug's cost and accessibility in India.
- The drug works by clearing amyloid plaques, a hallmark of Alzheimer's.
- Clinical studies showed donanemab slowed cognitive and functional decline by approximately 35%.
Eli Lilly's new Alzheimer's drug, donanemab, has received approval in India, offering a new treatment option for patients with early-stage cognitive impairment or mild Alzheimer's disease. Marketed as Lormalzi in India, the drug functions by clearing amyloid plaques in the brain, a key biological marker of the disease. This represents a shift towards therapies that aim to alter the disease's progression rather than just manage symptoms.
Despite the approval, Indian neurologists have voiced significant concerns about the drug's real-world impact. Key barriers identified include the high cost of the medication, potential delays in diagnosis, and the need for specialized monitoring. Experts also emphasize that the reported 35% slowing of cognitive and functional decline in clinical trials, as seen in the TRAILBLAZER-ALZ 2 study, should not be mistaken for a direct improvement in memory. Instead, it signifies a slower rate of deterioration, which may translate to preserving independence for a longer period for some patients.
Eli Lilly, through its India President and General Manager Winselow Tucker, stated that regulatory bodies conducted thorough reviews of the data and expressed confidence in the therapy's benefit-risk profile. The drug's launch comes at a time when India faces a substantial and growing burden of dementia, with an estimated 8.8 million people affected, the majority of whom have Alzheimer's disease. Globally, anti-amyloid drugs have faced debate regarding their cost-effectiveness and risk profiles, with some regulatory bodies initially expressing reservations before granting approvals.