A “GAME-CHANGING” drug shown to slow the progression of Alzheimer’s is set to be approved in the UK.
Lecanemab, developed by pharmaceutical company Eisai, is a targeted antibody treatment that binds to amyloid – a protein which builds up in the brains of people living with the disease.
GettyA drug to slow down Alzheimer’s is set to be approved in the UK[/caption]
It is designed to help clear the build-up and slow down cognitive decline and is given to patients via an intravenous drip fortnightly.
The decision from the UK’s medicines regulator is due to be announced shortly, but it is understood to have approved the treatment.
Lecanemab is already licensed in the United States, where it costs about £20,000 per patient per year.
It was, however, rejected by the European Medicines Agency (EMA) in July.
The EMA said the benefits of lecanemab did not counterbalance the risk of people suffering serious side effects, such as bleeding and swelling in the brain.
It also said the effects of the drug on delaying cognitive decline were small.
A similar drug called donanemab, which is developed by Eli Lilly, is also being assessed for approval in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).
NHS England estimates between 50,000 and 280,000 patients might be eligible for the new treatments.
Prior to being given the drugs, they will need to have a baseline MRI scan and then either a PET-CT scan or lumbar puncture to confirm Alzheimer’s.
In total, 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.
Lecanemab has been hailed by experts as “the beginning of the end” for the disease as it has been found to slow cognitive decline by 27 per cent in sufferers.
Professor John Hardy, chairman of molecular biology of neurological disease at the UCL Institute of Neurology, described the drug as “game-changing”.
“There is no question this is the biggest advance for 30 years,” he added.
In the old days you were going to get five years before nursing home, now you might get seven years before nursing home care
Professor John Hardy
In November 2022, when the results of trials were published, he said lecanemab was “the beginning of the end” for Alzheimer’s.
“It slows the disease by about 25 to 30 per cent 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,” Prof Hardy added.
Alzheimer’s Research UK said the same findings were a “historic moment” for dementia research.
This week’s potential 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.
An MHRA spokesperson told The Telegraph: “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.”
One of the first people to take the ‘miracle’ drug
She joined a trial of the medicine after a diagnosis of mild cognitive impairment (MCI) and a high risk of Alzheimer’s.
Joan, from Ohio, is still able to live independently and says her memory has improved.
She told The Sun: “I feel perfectly normal and I’m not having the issues that I was having.
“I’m totally functional and my memory is much better than it was.
“I’m very active, I drive regularly, I garden and cook, I read a number of books and I have my life back.”
Husband Larry, 77, added: “This drug is little short of a miracle, from our perspective.”
The couple have been married for 14 years since they met as widowers, and have a combined eight children and 25 grandkids.
Joan first noticed she was having memory problems in 2016 and tests confirmed she had MCI and Alzheimer’s plaques building up in her brain.
MCI is an early phase of memory loss which is worse than usual ageing but not as bad as dementia – although 10 to 15 per cent of sufferers go on to develop dementia.
Joan jumped at the chance to join the lecanemab trial at the Cleveland Clinic, which showed the drug reduced brain damage by an average of 27 per cent over 18 months.
It was the first medication fully proven to work this way and was hailed as a “game-changer”, though scientists warn it does not work for everyone and can have severe side effects.
Joan said: “I knew the Cleveland Clinic is a first class operation and when they thought they had a drug that might help – and I desperately needed help – I was going for it. I had no second thoughts.”
After the 18-month trial in 2020 and 2021, when she didn’t know if she was taking the drug or a placebo, Joan now injects herself with the real thing at home once a week.
It comes in an auto-injector similar to an epi-pen, a development since it was given by IV drip during the study.
She also has cognitive speech therapy alongside the medication.
Larry said: “When Joan was diagnosed my fears were that this would be a downward spiral.
“It used to be that when you mentioned Alzheimer’s you were looking into an abyss. Now this drug offers a great hope for the future.
“I’ve seen improvements in Joan’s short-term memory. She’s a fighter.”