Breakthrough medication could be available on the NHS by 2025, experts say

A new drug hailed as a “turning point in the fight against Alzheimer’s” after it was found to slow the progression of the disease could be available on the NHS within 18 months, experts believe.

Donanemab was found to slow “clinical decline” by up to 35 per cent, meaning that people with disease could still go about performing day-to-day tasks including shopping, housekeeping, managing finances and taking medication.

Scientists have now published the final results of the trial – known as TRAILBLAZER ALZ-2 – examining the safety and efficacy of the drug, manufactured by Eli Lilly and Company.

Researchers examined almost 1,800 people with early-stage Alzheimer’s. Half of them received a monthly infusion of donanemab and the other half were given a dummy drug, also known as a placebo, over 18 months. The drug works by removing a protein called amyloid that builds up in the brains of people with Alzheimer’s.

The study, published in the Journal of the American Medical Association and presented to the Alzheimer’s Association International Conference in Amsterdam, concluded that after 76 weeks of treatment, donanemab was able to slow clinical decline by 35.1 per cent in people with early Alzheimer’s whose brain scans showed low or medium levels of another protein called tau.

When the results were combined for people who had different levels of this protein, there was a 22.3 per cent slowing in disease progression. But researchers did find that among a small number of people in the study there were some serious side effects such as brain swelling. Three deaths in the donanemab group and one in the placebo group were also considered “treatment related”.

Eli Lilly and Company, the US manufacturers of the drug, said some people taking the drug would be able to finish the course of treatment in six months once their amyloid plaque cleared. It said treatment with donanemab reduced amyloid plaque on average by 84 per cent at 18 months, compared with a 1 per cent decrease for participants on placebo. Some 47 per cent of people taking the drug who had early-stage disease and low or medium levels of tau were found to stall the disease for a year.

The results come after trials showed another drug called lecanemab slowed progression of Alzheimer’s symptoms by 27 per cent in patients in the early stages of the disease. The drug was approved for use in the US earlier this month. The UK’s leading dementia charities urged Eli Lilly to put donanemab forward for regulatory review in the UK without delay.

The process of such drugs being approved for safety by the MHRA [Medicines and Healthcare products Regulatory Agency] and for cost-effectiveness by NICE can take several years, however experts are hopeful regulation could be fast-tracked.

Sian Gregory, Research Communications Manager from the Alzheimer’s Society, told i: “I think the earliest we could see donanemab on the NHS is 2025.

“The drug has shown evidence of slowing progression in the early stages of Alzheimer’s disease, so we would expect Eli Lilly to submit an application to the MHRA for regulatory review in the UK, especially as another drug was submitted in May.

“We hope both the MHRA and NICE make a swift decision as and when that happens.”

Dr Mark Mintun, group vice president of neuroscience research and development at Eli Lilly, said: “People living with early, symptomatic Alzheimer’s disease are still working, enjoying trips, sharing quality time with family – they want to feel like themselves, for longer. The results of this study reinforce the importance of diagnosing and treating disease sooner than we do today.”

However, the company said it is ready to work with health regulators in the UK as well as the NHS and the Government on the “appropriate regulatory next steps”.

However, many experts believe the NHS is nowhere near ready to provide the drugs to the huge numbers of people who need them, even if they are are approved quickly. Estimates by Alzheimer’s Research UK suggest 575,000 people in the UK would meet the treatment criteria used in the clinical trials of lecanemab and donanemab.

The drugs work best when given at the very first stages of Alzheimer’s, or earlier still when patients have what doctors call mild cognitive impairment. But experts say the NHS is unable to deliver that many early diagnoses of a condition which is currently detected at a later stage in most people.

Dr Richard Oakley, associate director of research and innovation at Alzheimer’s Society, said: “This is truly a turning point in the fight against Alzheimer’s and science is proving that it is possible to slow down the disease.

“Diagnosis will be key to the access of any new treatments. We can’t have a situation where treatments are approved for use in the UK but people aren’t diagnosed early or accurately enough to be eligible. We need early, and accurate, diagnoses available for everyone and the NHS ready to roll out treatments such as donanemab and lecanemab if and when they are approved in the UK.”

Several UK-based scientists not involved in the research acknowledged that as a potential first-generation treatment, donanemab’s effects are modest. Several pointed out that its serious side effects, like those of lecanemab, may put patients off taking it – and put doctors off prescribing the drug.

Dr Liz Coulthard, Associate Professor in Dementia Neurology at the University of Bristol, said: “The drug seems to have a meaningful benefit, at least for some patients. We do not yet know whether this benefit would continue after 18 months. There were significant side effects and patients will need to be aware of risks of treatment so they can choose whether they take these drugs or not.”

A spokesperson for the National Institute for Health and Care Excellence (Nice), said: “””Nice has already started work on its appraisal of donanemab for treating mild cognitive impairment or mild dementia caused by Alzheimer’s disease.

“Our aim is to produce recommendations on its use in the NHS as close as possible to it receiving its UK licence. To do this we are already talking to the NHS and the company.

“Whether a medicine is recommended by Nice is influenced by many factors including the evidence on how well it works but importantly also by its price, which is set by the company.”