Hyderabad: Alzheimer's, a progressive neuro-degenerative disease, has no cure. For decades, treatment has largely focused on managing symptoms rather than slowing the disease itself. That changed with the launch of Eli Lilly's anti-amyloid drug donanemab, branded as Lormalzi (Kisunla US, EU, etc.), and recently approved in India.But neurologists in India caution that its real-world impact in India could be limited by high costs, delayed diagnosis, lack of specialised monitoring requirements and most critically, questions revolving about the extent of benefit.Also read: US President Donald Trump exhibiting signs of dementia? Expert flags ‘warning signs’On its part, Winselow Tucker, President and General Manager, Eli Lilly and Company (India) says regulators had conducted thorough independent reviews of the data and that the company remains confident in the therapy's benefit-risk profile. The launch of donanemab comes as India faces a rapidly growing dementia burden. Dementia affects an estimated 8.8 million people in the country, with Alzheimer's disease accounting for the majority of cases, according to estimates cited by Eli Lilly.The Big DebateDonanemab is approved for patients with mild cognitive impairment or mild Alzheimer's disease, making early diagnosis critical. The drug works by clearing amyloid plaques in the brain, a biological hallmark of Alzheimer's, and is among a new generation of therapies designed to alter the course of the disease itself. In the Phase III TRAILBLAZER-ALZ 2 clinical study, donanemab slowed cognitive and functional decline by around 35% in patients with early symptomatic Alzheimer's.ET BureauDementia affects an estimated 8.8 m people in countryHowever, experts stress that the figure is often misunderstood. "The 35% slowing should not be interpreted as a 35% improvement in memory. Patients generally continue to show decline, but slower than expected. Some families may notice a meaningful delay in deterioration, while others may perceive little visible difference," Dr Sudhir Kumar, senior consultant neurologist at Apollo Hospitals Hyderabad says, adding that for some patients, that could mean preserving independence for longer and delaying the need for assistance.Also read: 'Dementia can start in your legs': Bengaluru neurosurgeon explains how inactive muscles can trigger cognitive declineThat distinction lies at the heart of a debate that has followed anti-amyloid drugs globally, with questions over whether the clinical benefit justifies the risks and cost. The European Medicines Agency initially issued a negative opinion on donanemab, citing concerns around its benefit-risk profile, before backing approval in a narrower patient population considered less likely to experience serious side effects.
Eli Lilly's Alzheimer's drug donanemab approved in India, but neurologists flag cost, access barriers
A new drug for Alzheimer's, donanemab, has arrived in India. It aims to slow the disease's progression by clearing brain plaques. While offering potential benefits, experts highlight concerns about its high cost and the need for early diagnosis. The drug's real-world impact in India remains a subject of discussion among neurologists and the company.









