How does donanemab fight Alzheimer’s? And when will it be approved in the UK and US? Everything you need to know about game-changing new drug
It’s been labelled a ‘milestone’ in the fight against Alzheimer’s.
But what is donanemab? How does the drug work? And what do the results actually show?
Here, MailOnline answers all of your questions.
Researchers today unveiled that donanemab slowed cognitive decline in Alzheimer’s by 35 per cent by removing toxic plaques in the brain
How does it work?
Donanemab is given to Alzheimer’s patients through an IV infusion once a month.
The monoclonal antibody — a man-made version of proteins produced by the body to fight-off harmful substances — travels to the brain
Once inside the organ, donanemab binds to toxic build-ups of amyloid plaque — a hallmark sign of the memory-robbing disease.
This prompts immune cells, known as microglia, to dissolve them.
Patients stop taking donanemab once the amyloid accumulation has been cleared from their brain.
Half of participants in a trial of the drug reached this point after one year, and seven in 10 stopped taking it within 18 months.
What did trial results show?
Eli Lilly, the US pharmaceutical firm behind the treatment, boasted that donanemab significantly slowed cognitive and functional decline for patients in the early stages of Alzheimer’s.
Researchers examined almost 1,800 people with early-stage Alzheimer’s, when the tell-tale memory loss first begins but before the cruel disease has managed to fully take hold.
Half of the volunteers received a monthly infusion of donanemab while the others were given a dummy drug, known as a placebo, over 18 months.
Donanemab was found to slow ‘clinical decline’ by 35.1 per cent in patients whose brain scans showed low or medium levels of tau — one of the two main proteins thought to interfere with the communication between brain cells among patients with dementia.
It means people with disease could still perform day-to-day tasks, such as shopping, housekeeping, managing finances and taking medication.
And 47 per cent saw no progression in their Alzheimer’s one year later.
When the results were combined for people who had different levels of tau, there was a 22.3 per cent slowing in disease progression, on average.
The final results from Phase 3 TRAILBLAZER-ALZ 2 study were presented today at the Alzheimer’s Association International Conference in Amsterdam.
Participants who took donanemab also had 84 per cent lower amyloid levels after 18 months, compared to a one per cent drop among the placebo group.
Is the drug dangerous?
Like any treatment, donanemab is not without risks.
Researchers found some serious side effects, such as brain swelling.
Brain bleeds occurred in 314 patients (36.8 per cent) in the donanemab group and 130 patients (14.9 per cent) in the placebo group.
From 1906 when clinical psychiatrist Alois Alzheimer first reported a ‘severe disease of the cerebral cortex’ to uncovering the mechanics of the disease in the 1980s-90s to today’s ‘breakthrough’ drug lecanemab, scientists have spent over a century trying to grapple with the brutal disease that robs people of their cognition and independence
Vaccines and antibodies, brain zapping helmets, oxygen therapy and stem cells are just some of the areas experts are exploring in the hunt for a cure for Alzheimer’s
In the group that received donanemab, three participants (0.4 per cent) died, which researchers said was linked to their treatment.
For comparison, there was one treatment-related death (0.1 per cent) in the placebo group.
Those who were given the drug were also more likely to have an infusion-related reaction, such as a fever, vomiting and headaches (9 per cent vs 0.5 per cent).
And 112 patients taking donanemab withdrew due to the side effects, compared to just 38 withdrawals among the placebo group.
When will it be available?
Eli Lilly has submitted data to the US Food and Drug Administration (FDA) and expects it to make a decision by the end of the year.
It is also applying to other regulators for approval, including the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
If approved by the MHRA, donanemab would need to be assessed by the National Institute for Health and Care Excellence (NICE) before it could be rolled out on the NHS. This process could take a couple of years.
How is it different to other new Alzheimer’s drugs?
Donanemab — which has yet to be given a brand name — works by binding to amyloid after it has formed plaques in the brain.
Lecanamab, also known as Leqembi, targets the protein as it begins to form fibres in the organ.
Less than a year ago, another drug, called lecanemab (pictured), was found to slash cognitive decline among those with the memory-robbing condition by 27 per cen t
Meanwhile, aducanumab attaches to amyloid at both stages.
Lecanamab and aducanumab were developed by Japanese and US pharmaceutical firms Eisai and Biogen.
Lecanamab has already been approved in the US but is still being examined by UK regulators.
Aducanumab was given the green light in the US but rejected by EU officials.
Isn’t there already drugs for Alzheimer’s?
Current Alzheimer’s drugs only temporarily improve some symptoms.
One option is Acetylcholinesterase (AChE) inhibitors, which increase levels of acetylcholine — a substance in the brain that helps nerve cells communicate.
Meanwhile, memantine blocks the effects of an excessive amount of a chemical in the brain called glutamate.
Additionally, there are medicines that can be taken to treat behaviour changes such as anxiety, agitation and aggression.
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