*By Laura Donnelly, Health Editor, 21 Aug 2024 – 09:30PM BST*
The first drug found to slow down Alzheimer’s is to be given the green light for use in Britain.
Lecanemab, hailed by experts as “the beginning of the end” for the disease, has been found to slow cognitive decline by 27 per cent in sufferers.
On Thursday, the Medicines and Healthcare Products Regulatory Agency (MHRA) is expected to grant approval for the treatment of early Alzheimer’s disease.
The ruling by the safety watchdog will mean it can be prescribed privately in Britain for the first time.
The National Institute of Health and Care Excellence will then advise on whether it should be rolled out by the NHS.
The drug, given every two weeks through an IV drip, is the first disease-modifying treatment to both slow cognitive decline and reduce the plaques associated with the disease.
Clinical trials found it slowed the decline in participants’ memory and functional thinking.
The treatment was authorised by the US Food and Drug Administration last year.
**Side effects risk**
However, the European Medicines Agency has been far more cautious. Last month it rejected a licence for the drug, saying that potential side effects including “swelling and potential bleedings in the brain” outweighed the impact it had on slowing the progression of Alzheimer’s disease.
The MHRA is expected to set out some exclusions to minimise the risk of side effects when it approves lecanemab.
They include patients with the APOE gene, carried by around one quarter of people. Those with the gene, which increases the risk of Alzheimer’s, have been found to have a greater risk of suffering amyloid-related imaging abnormalities (Aria), which are characterised by swelling and bleeding of the brain.
Patients taking some types of blood-thinning medication will also be excluded because of the increased risk of bleeds.
An MHRA spokesperson said: “We are currently completing a rigorous assessment of the evidence supporting lecanemab in the treatment of Alzheimer’s disease. Further information will be communicated in due course.”
While major trials have found that lecanemab, produced by Eisai, the Japanese pharmaceutical company, slows down the early stages of Alzheimer’s disease, its effectiveness depends on early diagnosis, using specialist scans and investigations.
Trial results last year were the first positive breakthroughs in treatment for almost three decades, suggesting that lecanemab slows the progress of the disease rather than just masking symptoms.
But the treatment requires far more diagnostic capacity, with MRI scanning, lumbar punctures and PET scanning needed to establish which cases will benefit from the drugs.
Lecanemab is designed to target and clear amyloid, one of the proteins that build up in the brains of people with Alzheimer’s at an early stage of the disease.
The study, called Clarity AD, was the largest to date to test a long-debated theory that clearing the amyloid toxic brain plaques might slow the progress of Alzheimer’s.
Scientists compared results of people taking the drug with those taking a placebo – or dummy drug. After 18 months, the drug was found to have slowed disease progression by 27 per cent.
The trials showed differences in the build-up of amyloid in the brain in scans of participants, with those taking the drug having lower levels than those taking the placebo.
The study found that the most common side effects were headaches and the Aria swelling.
In January 2023, lecanemab was authorised for use in the United States, using an “accelerated approval” process at a cost of $26,500 (£21,177) a year.
Rolling it out on the NHS would require a mass expansion of diagnostic capacity, to determine who could benefit, and require widespread use of gene tests.
An audit published earlier this month found that just 2.1 per cent of people with dementia undergo the specialist investigations that would be required.
Experts have also said that the effectiveness of such treatments depends on early diagnosis.
The National Audit of Dementia also found that average waiting times from referral to diagnosis have hit five months.
According to the Alzheimer’s Society, about 982,000 people in the UK are living with dementia. The figure is expected to reach 1.4 million by 2040.
Prof John Hardy, one of the world’s leading researchers in the field, said the drug was “game-changing”, describing it as “the biggest breakthrough in Alzheimer’s for decades”.
Prof Hardy, the chairman of molecular biology of neurological disease at the UCL Institute of Neurology, said: “There is no question this is the biggest advance for 30 years.”
When the results of trials were published back in November 2022, he described lecanemab as “the beginning of the end” for Alzheimer’s.
“It slows the disease. Slows it by about 25 to 30 per cent,” he said. “So, you know, maybe if in the old days you were going to get five years before nursing home now you might get seven years before nursing home care.”
Alzheimer’s Research UK said the same findings were a “historic moment” for dementia research.
Original_Success3895 on
My Grandad was in hospital 3 weeks ago and the doctor told us they could try to treat him but it probably wouldn’t work and he’d suffer less if just allowed to die naturally.
My Mum made the foolish decision to give him antibiotics.
He lingered for another 10 days in complete agony with invasive tests and a tube up his willie before finally succumbing like the doctor said he would.
Meanwhile he was blocking the bed for other people who had a fighting chance to survive.
We should have let him die. And the NHS needs to get better at telling people to make that harsh decision for the good of us all.
Edit: apparently this sub supports terminally ill people being kept alive in agony and blocking beds for people with a genuine chance of survival. The indignity and suffering my Grandad went through in his final week made it clear we’d made the wrong decision.
I’ve had enough Reddit today. This is genuinely the most upsetting thing I’ve ever seen on here. I think that worldview of keeping people around to suffer is disgusting frankly.
IXMCMXCII on
Not available on the NHS as it is too expensive.
Full_Maybe6668 on
Having seen my father die from Alzheimers I would gladly risk brain swelling rather than inflict it on myself and my family.
My father spoke several languages, ran his own business, was the life and soul of any party, but spent much of his final years scared and confused.
When he was too ill and his organs started shutting down, we watched for 10 days until he finally succumbed.
The reality of the illness is far removed from the glossy facade its given in the media
Traichi on
Really good news. Degenerative conditions such as Alzheimer’s, Huntingdon’s and Parkinson’s are honestly some of the scariest things I can think of happening. Your mind just stopping working is the worst way to live through life, any kind of progress is worth it to give sufferers even a few more months lucidity.
XenorVernix on
This is a good development but frustrating that it won’t be available on the NHS. Feels like the NHS is dying. You now need to pay for the NHS plus private healthcare to get full coverage. I guess treatments not being available on the NHS isn’t new but it feels like it is happening more often. What’s the solution here?
PerceptionGreat2439 on
Reading the thread, it’s already become a wasps nest.
Alzheimer’s wonder drug. What a great idea and if it’s effective and can make people’s lives’ better that’s got to be a good thing right?
Yes and no.
Yes, because watching anyone you know and care for, slip away into a world of oblivion, senility and confusion is absolutely heartbreaking. I know because I’ve been there. As other’s here are already saying because they’ve experienced it first hand, Alzheimer’s destroys everyone it meets. Not just immediate family and friends but carers and care home staff who work with it every day.
No because, this country has abandoned all efforts to care for it’s elderly population unless of course, they’re filthy rich. What’s the point of giving someone a better quality of life if they’re going to be left alone and ignored in the long term?
We have to start genuinely caring for our ageing population. A population that will only increase over the coming decades. You yourselves will be part of it one day.
7 Comments
Article contents:
*By Laura Donnelly, Health Editor, 21 Aug 2024 – 09:30PM BST*
The first drug found to slow down Alzheimer’s is to be given the green light for use in Britain.
Lecanemab, hailed by experts as “the beginning of the end” for the disease, has been found to slow cognitive decline by 27 per cent in sufferers.
On Thursday, the Medicines and Healthcare Products Regulatory Agency (MHRA) is expected to grant approval for the treatment of early Alzheimer’s disease.
The ruling by the safety watchdog will mean it can be prescribed privately in Britain for the first time.
The National Institute of Health and Care Excellence will then advise on whether it should be rolled out by the NHS.
The drug, given every two weeks through an IV drip, is the first disease-modifying treatment to both slow cognitive decline and reduce the plaques associated with the disease.
Clinical trials found it slowed the decline in participants’ memory and functional thinking.
The treatment was authorised by the US Food and Drug Administration last year.
**Side effects risk**
However, the European Medicines Agency has been far more cautious. Last month it rejected a licence for the drug, saying that potential side effects including “swelling and potential bleedings in the brain” outweighed the impact it had on slowing the progression of Alzheimer’s disease.
The MHRA is expected to set out some exclusions to minimise the risk of side effects when it approves lecanemab.
They include patients with the APOE gene, carried by around one quarter of people. Those with the gene, which increases the risk of Alzheimer’s, have been found to have a greater risk of suffering amyloid-related imaging abnormalities (Aria), which are characterised by swelling and bleeding of the brain.
Patients taking some types of blood-thinning medication will also be excluded because of the increased risk of bleeds.
An MHRA spokesperson said: “We are currently completing a rigorous assessment of the evidence supporting lecanemab in the treatment of Alzheimer’s disease. Further information will be communicated in due course.”
While major trials have found that lecanemab, produced by Eisai, the Japanese pharmaceutical company, slows down the early stages of Alzheimer’s disease, its effectiveness depends on early diagnosis, using specialist scans and investigations.
Trial results last year were the first positive breakthroughs in treatment for almost three decades, suggesting that lecanemab slows the progress of the disease rather than just masking symptoms.
But the treatment requires far more diagnostic capacity, with MRI scanning, lumbar punctures and PET scanning needed to establish which cases will benefit from the drugs.
Lecanemab is designed to target and clear amyloid, one of the proteins that build up in the brains of people with Alzheimer’s at an early stage of the disease.
The study, called Clarity AD, was the largest to date to test a long-debated theory that clearing the amyloid toxic brain plaques might slow the progress of Alzheimer’s.
Scientists compared results of people taking the drug with those taking a placebo – or dummy drug. After 18 months, the drug was found to have slowed disease progression by 27 per cent.
The trials showed differences in the build-up of amyloid in the brain in scans of participants, with those taking the drug having lower levels than those taking the placebo.
The study found that the most common side effects were headaches and the Aria swelling.
**NHS roll-out requires expanded diagnostic capacity**
In January 2023, lecanemab was authorised for use in the United States, using an “accelerated approval” process at a cost of $26,500 (£21,177) a year.
Rolling it out on the NHS would require a mass expansion of diagnostic capacity, to determine who could benefit, and require widespread use of gene tests.
An audit published earlier this month found that just 2.1 per cent of people with dementia undergo the specialist investigations that would be required.
Experts have also said that the effectiveness of such treatments depends on early diagnosis.
The National Audit of Dementia also found that average waiting times from referral to diagnosis have hit five months.
According to the Alzheimer’s Society, about 982,000 people in the UK are living with dementia. The figure is expected to reach 1.4 million by 2040.
Prof John Hardy, one of the world’s leading researchers in the field, said the drug was “game-changing”, describing it as “the biggest breakthrough in Alzheimer’s for decades”.
Prof Hardy, the chairman of molecular biology of neurological disease at the UCL Institute of Neurology, said: “There is no question this is the biggest advance for 30 years.”
When the results of trials were published back in November 2022, he described lecanemab as “the beginning of the end” for Alzheimer’s.
“It slows the disease. Slows it by about 25 to 30 per cent,” he said. “So, you know, maybe if in the old days you were going to get five years before nursing home now you might get seven years before nursing home care.”
Alzheimer’s Research UK said the same findings were a “historic moment” for dementia research.
My Grandad was in hospital 3 weeks ago and the doctor told us they could try to treat him but it probably wouldn’t work and he’d suffer less if just allowed to die naturally.
My Mum made the foolish decision to give him antibiotics.
He lingered for another 10 days in complete agony with invasive tests and a tube up his willie before finally succumbing like the doctor said he would.
Meanwhile he was blocking the bed for other people who had a fighting chance to survive.
We should have let him die. And the NHS needs to get better at telling people to make that harsh decision for the good of us all.
Edit: apparently this sub supports terminally ill people being kept alive in agony and blocking beds for people with a genuine chance of survival. The indignity and suffering my Grandad went through in his final week made it clear we’d made the wrong decision.
I’ve had enough Reddit today. This is genuinely the most upsetting thing I’ve ever seen on here. I think that worldview of keeping people around to suffer is disgusting frankly.
Not available on the NHS as it is too expensive.
Having seen my father die from Alzheimers I would gladly risk brain swelling rather than inflict it on myself and my family.
My father spoke several languages, ran his own business, was the life and soul of any party, but spent much of his final years scared and confused.
When he was too ill and his organs started shutting down, we watched for 10 days until he finally succumbed.
The reality of the illness is far removed from the glossy facade its given in the media
Really good news. Degenerative conditions such as Alzheimer’s, Huntingdon’s and Parkinson’s are honestly some of the scariest things I can think of happening. Your mind just stopping working is the worst way to live through life, any kind of progress is worth it to give sufferers even a few more months lucidity.
This is a good development but frustrating that it won’t be available on the NHS. Feels like the NHS is dying. You now need to pay for the NHS plus private healthcare to get full coverage. I guess treatments not being available on the NHS isn’t new but it feels like it is happening more often. What’s the solution here?
Reading the thread, it’s already become a wasps nest.
Alzheimer’s wonder drug. What a great idea and if it’s effective and can make people’s lives’ better that’s got to be a good thing right?
Yes and no.
Yes, because watching anyone you know and care for, slip away into a world of oblivion, senility and confusion is absolutely heartbreaking. I know because I’ve been there. As other’s here are already saying because they’ve experienced it first hand, Alzheimer’s destroys everyone it meets. Not just immediate family and friends but carers and care home staff who work with it every day.
No because, this country has abandoned all efforts to care for it’s elderly population unless of course, they’re filthy rich. What’s the point of giving someone a better quality of life if they’re going to be left alone and ignored in the long term?
We have to start genuinely caring for our ageing population. A population that will only increase over the coming decades. You yourselves will be part of it one day.