The launch of Eli Lilly's Alzheimer's therapy Lormalzi (donanemab) in India marks a significant shift in the treatment of the neurodegenerative disorder, with experts describing it as one of the first therapies aimed at slowing progression of the disease in its early stages rather than merely managing symptoms.
Dr Manjari Tripathi, head of Neurology at AllMS, Delhi, said while the availability of such drugs was "good news", these were suitable only for patients in the earliest stages of Alzheimer's disease or mild cognitive impairment.
"Patients have to come to us very, very early. Most patients in India are brought to us in the middle stage of the disease, so this requires a paradigm shift in diagnosis," she said.
Dr Tripathi cautioned that the therapy is expensive and not free from adverse effects, including brain swelling and microbleeds in some patients, making proper counselling and informed consent essential.
"The diagnosis has to be made not just on clinical features, but also on biomarker detection through plasma or cerebrospinal fluid tests," she said, adding that recent meta-analyses showed the benefits, though meaningful, may not be "very dramatic".
The injectable therapy, approved for patients with mild cognitive impairment (MCI) or those in the early stage of dementia due to Alzheimer's disease, is expected to be introduced in India later this month.
Unlike conventional Alzheimer's drugs that largely manage memory loss and behavioural symptoms, donanemab targets amyloid-beta plaques ' abnormal protein deposits linked to the disease.
According to Eli Lilly, Lormalzi is administered once every month and treatment can be stopped after plaque reduction reaches the desired level.
The company has priced the 350 mg vial at Rs 91,688 per month and said patient access programmes would also be introduced.
Neurologists, however, cautioned that the treatment is not a cure and is suitable only for carefully selected patients diagnosed at an early stage of the disease.
Dr Vinit Suri, senior consultant of neurology at Indraprastha Apollo Hospital, said the new generation of Alzheimer's drugs offered a fundamentally different treatment strategy.
"Instead of only helping manage symptoms, these therapies are designed to slow the progression of the disease by targeting the underlying changes in the brain," he said.
"The potential benefit is that they may help preserve memory and cognitive function for a longer period, especially when used in patients with mild cognitive impairment or very early memory decline," he added.
Experts noted that identifying the right patients remains critical.
Patients are generally required to undergo amyloid testing through positron emission tomography (PET) scans or cerebrospinal fluid analysis before starting treatment.
Dr Vinit Banga, director of neurology at Fortis Hospital, Faridabad said the treatment is specifically meant for patients with mild cognitive impairment or mild dementia due to Alzheimer's disease.
Before initiating therapy, proper patient selection is extremely important, he emphasised.
"Patients need confirmation of amyloid pathology through CSF or serum beta-amyloid biomarkers, and a baseline MRI brain is necessary prior to starting treatment. The drug is administered as monthly intravenous infusions and can be continued for a maximum duration of around 18 months.
"Periodic MRI brain monitoring is also required during treatment because of potential complications such as amyloid-related imaging abnormalities (ARIA), including brain edema or microbleeds," Dr Banga said.
Side effects may include headache, dizziness, nausea and confusion, although these have largely remained manageable in most patients, Dr Suri said.
He Suri pointed out that amyloid PET imaging is still not widely available in India, which could limit adoption.
In the context of the Indian healthcare ecosystem, where 10 million people are living with dementia, which is projected to double by 2036, the availability of such biologics is noteworthy, said Dr M V Padma Srivastava, chairperson of neurology at Paras Health.
She explained that donanemab is a monoclonal antibody that helps clear amyloid plaques from the brain, making it fundamentally different from older therapies.
"What also makes this treatment different is that it is not meant to be taken forever. It is usually given as a monthly infusion for about 18 months, or until scans show that the plaques have reduced to a target level," she said, describing it as a 'treat-to-target" approach.
She, however, stressed that "its effectiveness is heavily dependent on proper diagnosis in a timely manner, with patients requiring confirmation of their condition by undergoing positron emission tomography or cerebrospinal fluid tests." Moreover, the treatment demands close supervision regarding Amyloid-Related Imaging Abnormalities (ARIA), she underlined.
Accessibility is also expected to remain a challenge. Dr Suri estimated that the overall treatment cost over 18 months could range between Rs 50 lakh and Rs 60 lakh, making affordability a major concern for most patients.
Even so, neurologists believe the therapy signals the beginning of a new phase in Alzheimer's treatment in India, where disease-modifying drugs may gradually complement traditional symptom-management approaches.
"Although challenges related to cost, biomarker testing and monitoring infrastructure remain, this therapy marks the beginning of a new era in Alzheimer's care in India," Dr Banga stated.
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