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‘Game-changing’ Alzheimer’s drug that ‘slows decline by 60%’ is approved in US – as UK decision expected within months
Experts say it marks another important milestone in the global fight against the disease
A "GAME-CHANGING" Alzheimer's drug that slows mental decline by up to 60 per cent has been approved in the United States.
Donanemab, sold in the US under the brand name Kisunla, will be available for patients with early symptoms of the disease.
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The medicine remains under consideration by Britain's regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
A decision is expected in the coming months.
Samantha Benham-Hermetz, executive director of policy and communications at Alzheimer’s Research UK, said: "Today’s decision by the regulators in the US marks another important milestone in the global effort to tackle dementia.
"We are hopeful that a decision will be made later this year for Great Britain."
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Donanemab, made by pharmaceutical company Eli Lilly, is an antibody-based treatment designed to remove amyloid - one of the hallmark proteins that builds up in the brains of people with Alzheimer’s.
It is given as an infusion into a person’s arm once a month.
Clinical trials have found it cleared toxic proteins out of patients’ brains and slowed mental decline by up to 60 per cent over 18 months.
It was most effective for people in the earliest stages of Alzheimer’s – the top cause of dementia – and slowed decline by 36 per cent on average.
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Among all participants, treatment with donanemab reduced amyloid plaque on average by 84 per cent at 18 months, compared with a one per cent decrease for participants taking a placebo.
The Food and Drug Administration (FDA) in the US will offer donanemab to patients with early symptomatic Alzheimer's disease.
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This includes people with mild cognitive impairment (MCI), as well as those with the mild dementia stage of Alzheimer’s, with confirmed amyloid pathology.
When prescribed, doctors must monitor for side effects such as brain swelling, known as amyloid-related imaging abnormalities (ARIA), and infusion related reactions.
Patients who have two APOE4 genes, associated with a higher risk of Alzheimer's, are more likely to develop ARIA than those with just one copy or non-carriers.
The FDA recommends testing for APOE4 status before beginning treatment.
Anne White, executive vice president at Eli Lily, said: "Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer's disease.
"This brings hope to people who urgently need new treatment options.
"We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis."
While drugs like donanemab are a promising start, we need to go further
Samantha Benham-Hermetz
Fiona Carragher, director of research and influencing at Alzheimer’s Society, added: "This marks another step forward in the fight against dementia, the biggest health and social care challenge of our time.
"But there are still many hurdles before donanemab could be available on the NHS."
While Dr Suzanne Schindler, a neurologist at Washington University in St Louis, said: "I'm thrilled to have different options to help my patients.
"It's been difficult as a dementia specialist - I diagnose my patients with Alzheimer's and then every year I see them get worse and they progress until they die."
What do the UK experts say?
Samantha Benham-Hermetz, executive director of policy and communications at Alzheimer’s Research UK, said:
"Today’s decision by the regulators in the US marks another important milestone in the global effort to tackle dementia.
"Donanemab is built on decades of scientific discovery and is one of the first drugs to be proven effective at slowing the destructive course of Alzheimer’s disease.
"There is still some way to go before donanemab might reach patients in Great Britain.
"It’s important that the Medicines and Healthcare products Regulatory Agency (MHRA) looks independently at the full clinical trial data to reassure themselves that the benefits of donanemab outweigh the risks for people living with early Alzheimer’s disease in Great Britain, and that the treatment is safe and clinically effective.
"We are hopeful that a decision will be made later this year.
"While drugs like donanemab are a promising start, we need to go further.
"As with many first-generation treatments, donanemab’s benefits are modest, and come with risk of serious side-effects.
"It is only used to treat people with early Alzheimer’s disease meaning that sadly, most people living with dementia won’t benefit.
"The next government must push forward the work of the Dame Barbara Windsor Dementia Mission, to ensure the health system is ready to lead the adoption of innovative new Alzheimer’s drugs, and help accelerate research that will bring us closer to a cure for all forms of dementia.
"The outlook for people with dementia is finally changing, and it’s more important than ever that the UK is a global leader in accelerating progress."
In Alzheimer's disease, two key proteins, tau and amyloid beta, build up into tangles and plaques, known together as aggregates, which cause brain cells to die and lead to brain shrinkage.
Donanemab is the second drug proven to prevent and reverse this process.
It follows lecanemab, which results last year showed a slowed decline by 27 per cent.
Around 900,000 Brits have dementia, with Alzheimer’s responsible for two in three cases. It is the UK’s top killer.
Cases are on the rise with still no hope of a cure as current medications can only reduce symptoms.
The MHRA is deciding whether the two drugs are safe and effective enough to be made available in the UK.
The National Institute for Health and Care Excellence (NICE) will then consider whether they should be offered on the NHS.
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The drugs can cause severe side effects, even including death, don’t work for all patients and are likely to be very expensive.
Experts also warn the NHS does not yet have enough capacity or brain scanners to roll them out to everyone who could benefit.
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What are the early symptoms of cognitive decline?
WE all notice a natural decline in memory and thinking as we age.
This will be more pronounced in some people, as they experience memory and thinking problems that are mild but still noticeable.
This is described as mild cognitive impairment (MCI). Unlike dementia sufferers, people with MCI can still get on with day-to-day life.
Research suggests that two out of 10 people over the age
of 65 have MCI, according to Alzheimer's Research UK.
About one in 10 people who've received an MCI diagnosis will go on to develop dementia.
Symptoms of MCI include:
Memory - Misplacing items or having trouble
remembering recent conversations.
- Attention problems - finding it difficult to concentrate,
e.g. while watching a TV programme or carrying out
duties at work - Disorientation - confusion about time, date or place
- Thinking skills - problems with planning or completing
tasks, e.g. managing money, or cooking a meal - Problems with communication and finding the right words
- Mood and behaviour changes - becoming irritable, anxious,
or feeling low
These symptoms may affect someone with MCI all the
time, or they might come and go.
There are steps we can take to keep our brains as healthy as possible. These include:
- Not smoking
- Doing regular physical activity
- Staying mentally and socially active
- Eating a healthy balanced diet
- Limiting the amount of alcohol we drink
- Having your hearing checked regularly
- Keeping blood pressure, blood sugar and cholesterol
levels in check
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