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Straits Times
3 days ago
- Health
- Straits Times
What to know about 2 new Alzheimer's disease drugs approved in Singapore
Find out what's new on ST website and app. One factor that could stand in the way of wider acceptance of these drugs is their costliness. SINGAPORE – Tackling Alzheimer's disease in Singapore received a boost earlier in 2025, when the authorities approved two new drugs for the neurodegenerative disease. Although these drugs – lecanemab and donanemab – cannot cure or reverse the effects of Alzheimer's, they have been shown to slow the progression of the disease, which accounts for almost 70 per cent of dementia cases worldwide. Simply Science looks at what these drugs do, how effective they are, as well as the risks and costs. How do they work? The two new drugs are monoclonal antibodies, which are lab-produced proteins that mimic natural antibodies. They work by targeting and removing beta-amyloids – molecules that accumulate in the frontal cortex and hippocampus of the brain – causing Alzheimer's disease. Lecanemab, which is marketed as Leqembi, is developed by pharmaceutical firms Eisai, Biogen and BioArctic. Donanemab, marketed as Lormalzi in Singapore and Kisunla in other countries, is developed by Eli Lilly. Top stories Swipe. Select. Stay informed. Singapore Sewage shaft failure linked to sinkhole; PUB calling safety time-out on similar works islandwide Singapore Tanjong Katong Road sinkhole did not happen overnight: Experts Singapore Workers used nylon rope to rescue driver of car that fell into Tanjong Katong Road sinkhole Asia Singapore-only car washes will get business licences revoked, says Johor govt World Food airdropped into Gaza as Israel opens aid routes Sport Arsenal beat Newcastle in five-goal thriller to bring Singapore Festival of Football to a close Singapore Benchmark barrier: Six of her homeschooled kids had to retake the PSLE Asia S'porean trainee doctor in Melbourne arrested for allegedly filming colleagues in toilets since 2021 Both are intravenous injections – lecanemab is administered every two weeks over about 1½ years, and donanemab is administered every four weeks over the same period. How effective are they? During clinical trials, both drugs demonstrated the ability to slow Alzheimer's disease. Findings from the clinical trial of lecanemab, published in the New England Journal of Medicine, showed that it slowed decline for people with early Alzheimer's disease by about 27 per cent to 37 per cent. Meanwhile, results from donanemab's Phase 3 clinical trial, published in the Journal of the American Medical Association, showed that the drug slowed cognitive decline by about 20 per cent to 29 per cent. Eisai medical director Amitabh Dash said lecanemab differs from existing drugs, which treat symptoms and manage memory or behavioural issues only temporarily. 'It works by clearing these protofibrils and amyloid plaques, which are believed to contribute to the progression of the disease,' said Dr Dash. Protofibrils refer to protein aggregrates such as beta-amyloids. Lecanemab was approved by the US Food and Drug Administration (FDA) in 2023, and by the Medicines and Healthcare products Regulatory Agency in Britain in 2024. Donanemab received FDA approval in 2024, and was also approved in Britain that year. In Singapore, the Health Sciences Authority (HSA) confirmed that the two drugs had been approved for use earlier in 2025. 'They are prescription-only medicines, and the treatment should be initiated by a physician experienced in the diagnosis and treatment of Alzheimer's disease,' HSA told The Straits Times. What are the side effects? For both drugs, the common side effects include infusion-related reactions such as fever, body aches and joint pains. However, the drugs have also been known to cause amyloid-related imaging abnormalities, known as Aria, a condition that can cause brain swelling or bleeding. In many cases, the condition is asymptomatic. But in more severe cases, it can cause seizures, or even death in rare instances. 'MRI monitoring is recommended during treatment to manage this risk safely,' said Dr Dash, referring to magnetic resonance imaging. What has been the response in Singapore to the drugs? Doctors in Singapore who have prescribed lecanemab described their experience as largely positive. Dr Lee Kim En, a neurologist at Mount Elizabeth Hospital, prescribed the drug to 27 patients, who had symptoms such as memory loss affecting their daily lives and difficulty in performing familiar tasks, including handling personal and financial matters. Most patients had shown a favourable response to the treatment, with a slowing in disease progression and preservation of cognition. 'Only one patient experienced mild confusion, disorientation for several hours after his first treatment,' Dr Lee added. He described lecanemab as a 'breakthrough treatment' for patients in the early stages of Alzheimer's disease. 'Without intervention, the time course of deterioration may take four to eight years, requiring full-time care and assistance for all aspects of daily living,' he said. Associate Professor Adeline Ng, a senior consultant at the National Neuroscience Institute's neurology department, had prescribed lecanemab to two women below the age of 65 who were diagnosed with mild Alzheimer's and had gradual mild cognitive decline. While on treatment, they were able to be more engaged with their families and maintain their ability to look after their daily needs, Prof Ng said, noting that neither had side effects. She intends to continue prescribing lecanemab, describing the treatment as 'the start of an era of new drug treatments' that could potentially modify the disease course for patients. Prof Ng stressed that such drugs are effective only in the early stages of Alzheimer's and are not a cure. Rather, they delay progression to the next stage of the disease by about six to eight months. 'The drug is also not suitable for some patients, such as those who have had previous strokes or who take certain blood thinning medication, due to the increased risk of bleeding in the brain,' she added. What are the costs? One factor that could stand in the way of wider acceptance of these drugs is their costliness. In the United States, lecanemab treatment is priced at US$26,500 (S$33,900) per year, while donanemab costs about US$32,000 annually. Britain's National Institute for Health and Care Excellence has declined to recommend both drugs for routine use under the publicly funded National Health Service, due to the high costs of purchasing and administering the drugs, and a lack of evidence on their long-term effects. In Singapore, the prices of the two drugs are not publicly available. However, the Ministry of Health said it is evaluating the clinical efficacy and cost-effectiveness of the two drugs to decide whether to subsidise them in the future. Dr Dash said such drugs represent a paradigm shift in the approach to Alzheimer's, noting that early diagnosis and treatment will become increasingly important due to the ageing populations in Singapore and across the region. 'The availability of Leqembi may drive healthcare systems to adopt biomarker-based diagnosis, improve infrastructure for safe infusion and monitoring, and offer patients more hope for slowing disease progression rather than only managing symptoms,' he said. Simply Science is a series that looks at the science behind everyday questions.
Euronews
6 days ago
- Health
- Euronews
EU regulator backs new Alzheimer's drug, months after rejecting it
The European Union's medicines regulator is reversing course on its decision to block a new Alzheimer's disease treatment, saying the drug can be offered to certain patients under strict safety protocols. In late March, the European Medicines Agency's (EMA) drug evaluators said the risks did not outweigh the benefits for the medicine donanemab, which can slow the progression of early-stage Alzheimer's but also raises the risk of potentially deadly brain swelling and bleeding. But in a revised opinion on Friday, the group said donanemab can be offered to a specific subset of Alzheimer's patients in tightly controlled settings. Donanemab, which is sold by Eli Lilly as Kisunla, is a monoclonal antibody taken via a once-monthly infusion. It's already been approved in the United Kingdom, the United States, Japan, and China. In a clinical trial, Kisunla slowed dementia symptoms by up to 35 per cent over 18 months – but three people died with serious amyloid‑related imaging abnormalities (ARIA), which are a common side effect of the medicine that can cause swelling and bleeding in the brain. Two of these patients carried a type of gene that raises the risk of Alzheimer's, and Lilly had suggested that the medicine only be offered to people who do not have the gene. In March, the EMA committee said that people without the gene were still at risk of fatal complications from ARIA. On Friday, the group said the drug can be offered to early Alzheimer's patients who have at most one copy of the gene – but only in a controlled access programme with medical teams that know how to detect and treat ARIA. Patients must also start at a lower dose. The EMA said that with those measures in place, its advisory group 'concluded that Kisunla's benefits outweigh its risks in noncarriers and people with just one copy' of the gene. The European Commission has the final say on whether a new drug or vaccine is approved, but it usually adopts the EMA evaluators' recommendations. That's why drugmaker Lilly had asked the EMA group to reconsider its negative opinion on Kisunla. It argued that ARIA is usually temporary and does not cause symptoms in most cases. Alzheimer's groups were also disappointed by the initial decision. At the time, Alzheimer Europe said that while patient safety is important, strict prescribing rules and safety monitoring could help ensure dementia patients have access to the new drug while keeping it away from those at higher risk of serious side effects. Notably, the EMA and the Commission recently greenlit another Alzheimer's drug, Leqembi, that comes with similar side effects for people with the gene. In that case, the EMA group had also first refused the drug, but later recommended that it be offered to people with only one or no copies of the gene – making it the first medicine of its kind authorised in the EU. The Commission is expected to make a final decision on Kisunla in the coming months.
The Independent
19-06-2025
- Health
- The Independent
Why two Alzheimer's drugs were rejected for use on the NHS
The National Institute for Health and Care Excellence (Nice) has rejected two Alzheimer's drugs, Donanemab and Lecanemab, for use on the NHS. Nice determined that the drugs offer only 'modest benefits at best,' delaying disease progression by four to six months in early stages. The decision was based on the drugs' limited benefits not justifying their high cost, estimated to be between £500 million and £1 billion annually for the NHS. Donanemab and Lecanemab are targeted antibody drugs that work by clearing amyloid protein buildup in the brain to slow cognitive decline. Scientists and doctors remain divided on the drugs' clinical significance, with some highlighting their potential while others raise concerns about the small benefits and serious side effects observed in trials.
ITV News
19-06-2025
- Health
- ITV News
Alzheimer's drugs rejected for NHS because benefits ‘too small' to justify cost
Two drugs to treat Alzheimer's disease have been rejected for use on the NHS because their benefits are 'too small' to justify their cost, the health spending watchdog has said. The National Institute for Health and Care Excellence (Nice) is standing by its earlier decision to turn down donanemab and lecanemab after considering new information submitted by manufacturers. Charities described the decision as 'disappointing' and a 'painful setback' for patients, while the firms Lilly, which makes donanemab, and Eisai, which makes lecanemab, said they would appeal. Donanemab and lecanemab are targeted antibody drugs that slow down the early stages of Alzheimer's. They represent a huge step forward in research because they target a known cause of the disease, rather than just treating symptoms. Both drugs bind to amyloid, a protein which builds up in the brains of people living with Alzheimer's disease. By binding to amyloid, the drugs are designed to help clear the build-up and slow down cognitive decline. Publishing its final draft guidance, Nice said the treatments have been shown to delay progression from mild to moderate Alzheimer's by four to six months. But it said the medicines cannot be provided on the NHS because they are not good value for money and 'only provide modest benefits at best'. Last year, NHS England published a briefing paper suggesting the cost of bringing the drugs to the health service could be £500 million to £1 billion per year. Professor Fiona Carragher, Alzheimer's Society's chief policy and research Officer, said the decision was 'disappointing'. The fact is, even if donanemab and lecanemab were made available on the NHS tomorrow, too many patients wouldn't be able to access them because the health system isn't ready to deliver them Professor Fiona Carragher, Alzheimer's Society She said: 'There is no doubt that today's decision is a setback for people with Alzheimer's disease. 'It is highly disappointing that we are in a situation where treatments that slow the progression of the condition are not available on the NHS. 'The reality we're faced with is that these treatments remain out of reach of both the NHS and most eligible people with Alzheimer's disease. 'In other diseases like cancer, treatments have become more effective, safer and cheaper over time. It's essential we see similar progress in dementia. 'The fact is, even if donanemab and lecanemab were made available on the NHS tomorrow, too many patients wouldn't be able to access them because the health system isn't ready to deliver them. 'The science is flying but the system is failing.' She said the Government must now commit to 'the long-term investment needed to fundamentally change dementia diagnosis so that we are ready for new treatments', including bringing in earlier diagnosis and access to specialist diagnostic tests. She added: 'We are heading towards a future where disease-slowing treatments reduce the devastating impact of dementia, and we cannot afford to delay preparing the NHS for them.' Hilary Evans-Newton, chief executive of Alzheimer's Research UK, said: 'This rejection is a painful setback for people affected by Alzheimer's – but sadly not a surprising one. 'The drugs' modest benefits, combined with the significant costs of delivering them in the NHS, meant they faced insurmountable challenges. 'People with early Alzheimer's in England and Wales now face a long wait for innovative new treatments as they won't be able to access lecanemab or donanemab unless they can afford to pay privately. 'This decision sends a troubling signal to the life sciences sector – undermining confidence in the UK as a home for research, innovation and clinical trials. That risks lasting damage to both patients and the economy. People with early Alzheimer's in England and Wales now face a long wait for innovative new treatments as they won't be able to access lecanemab or donanemab unless they can afford to pay privately Hilary Evans-Newton, Alzheimer's Research UK 'Nice's decision should ring alarm bells for a Government that, only a year ago, pledged to make the UK a global leader in dementia treatments. 'With over 30 Alzheimer's drugs now in late-stage trials globally, momentum is building – and more will enter regulatory systems in the years ahead. 'Without intervention from Government, people with Alzheimer's will continue to miss out — not because science is failing, but because the system is.' Helen Knight, director of medicines evaluation at Nice, said: 'While we recognise the hope these treatments offer, the evidence shows they only provide modest benefits at best and substantial resources would be needed to provide them. 'The committee accepted that any slowing of the disease getting worse would be meaningful for people with mild cognitive impairment or mild dementia caused by Alzheimer's disease and their carers because it could mean more time socialising, driving and being independent, so needing less help day-to-day from family members. 'But the committee concluded the small benefits to patients shown in the clinical trials and the lack of long-term evidence of effectiveness balanced with the substantial resources the NHS would need to commit to the treatments would be too great and could displace other essential treatments and services that deliver substantial benefits to patients. 'We have done everything we possibly can to try and achieve a positive outcome in our assessments of these treatments, including providing an additional opportunity for evidence to be submitted. 'We realise today's news will be disappointing for many, but we now need to focus on the encouraging pipeline of new Alzheimer's drugs in development, a number of which are already earmarked for Nice evaluation.' Drug firms and registered patient groups now have until July 8 to appeal against the decision. In clinical trials, donanemab, which is given via a drip, has been shown to slow the rate at which memory and thinking get worse by more than 20%. Results also suggest the drug leads to a 40% slowing in the decline of everyday activities such as driving, enjoying hobbies and managing money. Lecanemab – also administered via drip – has been shown to successfully remove protein build-up from the brains of people living with early Alzheimer's disease. For people taking lecanemab, this meant the decline in their thinking and memory skills was slowed down by 27%. It also slowed down the decline in quality of life by up to 56%. However, side-effects of the drugs can be serious, including brain bleeds and risk of death. A reformulation of lecanemab is being developed so it can be administered subcutaneously under the skin. Nice could then review the drug in this form. Lilly said it would appeal the Nice decision on the grounds it was unreasonable based on the evidence submitted. Chris Stokes, president and general manager of UK and Northern Europe at Lilly, said: 'If the system can't deliver scientific firsts to NHS patients, it is broken. 'If the Government is to deliver on its goals to reduce lives lost to the biggest killers and put Britain at the forefront of transforming treatment for dementia, it must keep pace with licensed medical breakthroughs.' Dr Jeremy Isaacs, national clinical director for dementia at NHS England, said: 'NHS England has a dedicated team preparing for the rollout of new Alzheimer's treatments. 'There are several other Alzheimer's treatments in development, and the NHS stands ready to offer patients access to new treatments as soon as they are deemed by regulators to be clinically and cost effective.'
The Independent
19-06-2025
- Health
- The Independent
How do the new antibody drugs for Alzheimer's disease work?
Two new drugs for Alzheimer's have been rejected for use on the NHS. They slow progression of the disease, but they can have serious side-effects. – What are the medicines? Donanemab and lecanemab are targeted antibody drugs that slow down the early stages of Alzheimer's. They represent a huge step forward in research because they target a known cause of the disease, rather than just treating the symptoms. Both drugs bind to amyloid, a protein which builds up in the brains of people living with Alzheimer's disease. By binding to amyloid, the drugs are designed to help clear the build-up and slow down cognitive decline. – How effective are they? Donanemab has been shown in clinical trials to slow the rate at which memory and thinking get worse by more than 20%. Evidence suggests that people get the most benefit if they are given the treatment earlier in the disease. Results also suggest the drug leads to a 40% slowing in the decline of everyday activities such as driving, enjoying hobbies and managing money. Lecanemab has also been shown to successfully remove protein build-up from the brains of people living with early Alzheimer's disease. For people taking lecanemab, this meant the decline in their thinking and memory skills was slowed down by 27%. It also slowed down the decline in quality of life by up to 56%. – How are the drugs given? Donanemab, developed by the pharmaceutical company Lilly, is given to patients via an intravenous drip once every four weeks. Lecanemab, developed by Eisai, is also given this way but fortnightly. – Are there any side-effects? Side-effects of the drugs can be serious and people undergo monitoring to check for them. In one clinical trial published in the Journal of the American Medical Association (JAMA) in 2023, 24% of people receiving donanemab had side-effects including brain swelling and infusion-related reactions. Four people died during the trial, with their deaths thought to be related to the drug's side-effects. Lecanemab resulted in infusion-related reactions in around 26% of people on the trial and followed up, while 14% suffered amyloid-related imaging abnormalities causing brain swelling. Others suffered minor bleeds picked up on scans. Around one in 10 people suffered headaches, according to updated results published in May 2024. Overall, four deaths during the follow-up period were thought to be due to treatment. – How much do the drugs cost? NHS England published a briefing paper last year suggesting the cost of bringing the drugs to the health service could be £500 million to £1 billion per year. Around 50%-60% of the total estimated cost relates to the drug price, with remaining cash spent on patient assessment, diagnosis and administering the treatment. – How many people in England might the drugs have worked for? NHS England estimated between 50,000 and 280,000 patients could be eligible for the new treatments if they were approved for the NHS. To get the drugs, patients need a baseline MRI scan and then either a PET-CT scan or lumbar puncture to confirm Alzheimer's. It is possible that blood tests will be available in the future to diagnose the disease, so NHS England did warn there should be caution about driving a 'massive expansion' in other diagnostics which could become redundant in the longer term. -What do scientists think? Scientists and doctors have been divided on whether the drugs represent a real clinical benefit that is noticeable in patients day-to-day. Some argue the drugs represent a huge advance and people should be given the chance to try them. But others say the benefits are too small. Jennifer Keen, associate director of evidence, policy and influencing at the Alzheimer's Society, has said: 'we remain at an important and exciting moment', adding: 'There are currently 182 active clinical trials for Alzheimer's disease… We are on the cusp of major scientific breakthroughs beginning to improve the outlook for those with the disease.' Professor Rob Howard, from University College London, said: 'Nobody should be surprised that Nice have confirmed their earlier view that the new Alzheimer's disease treatments would not be cost-effective if used within the NHS. 'Well-conducted clinical trials demonstrated that the actual size of benefits experienced by patients were too small to be noticeable, treatment carries risks of side-effects, and the annual cost of the drugs and safety monitoring required would have been close to the cost of a nurse's salary for each treated patient. We need better treatments that can make an appreciable difference to the lives of people with dementia and these can only come from further research and study.'
