A “GAME-CHANGING” drug shown to slow the progression of Alzheimer’s has been 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.
It is designed to help clear the build-up and slow down cognitive decline, and is given to patients via an intravenous drip fortnightly.
Lecanemab is already licensed in the United States, where it costs about £20,000 per patient per year, as well as in China, Japan, Hong Kong, South Korea and Israel.
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.
The decision from the UK’s medicines regulator on lecanemab was confirmed today.
Julian Beach, the Medicines and Healthcare products Regulatory Agency (MHRA) interim executive director, healthcare quality and access, said: “Licensing medicines which meet acceptable standards of safety, quality and efficacy is a key priority for us.
“We’re assured that, together with the conditions of the licence approval, the appropriate regulatory standards for this medicine have been met.
“As with all medical products, we will keep its safety under close review, and with a controlled post-authorisation safety study to be undertaken, we will ensure that the benefit risk of lecanemab in clinical use is closely followed up.”
A similar drug called donanemab, which is developed by Eli Lilly, is also being assessed for approval in the UK by the MHRA.
NHS England estimates between 50,000 and 280,000 patients might be eligible for the new treatments.
Lecanemab is approved to treat adults in the early stages of Alzheimer’s who have one or no copies of the APOE4 gene.
About 15 per cent of those diagnosed have two copies and are at increased risk, while people with one copy also have an increased risk.
Prior to being given the drugs, patients 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.
Today’s news is bittersweet for people affected by Alzheimer’s disease
Hilary Evans-Newton,
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 ruling by the safety watchdog means it can now be prescribed privately in Britain for the first time.
But the National Institute of Health and Care Excellence (NICE) has advised that the benefits of lecanemab are too small to justify the cost to the NHS.
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.”
Hilary Evans-Newton, chief executive at Alzheimer’s Research UK, said: “Today’s news is bittersweet for people affected by Alzheimer’s disease.
“It’s a remarkable achievement that science is now delivering licensed treatments that can slow down the devastating effects of Alzheimer’s, rather than just alleviating its symptoms.
“However, it’s clear our health system isn’t ready to embrace this new wave of Alzheimer’s drugs.
“It means that, as things stand, people in the early stages of the disease will be denied access to lecanemab through the NHS, and it will only be available to those who can pay privately. This is deeply disappointing.
“Of course, like first-generation treatments for other diseases, lecanemab has modest benefits and side effects that need careful monitoring.
“It’s not a cure, but it is a real step forward – the first new dementia medicine to be licensed in more than 20 years.
“Further negotiations between NICE, Eisai and the NHS may offer a way forward, but the heartbreaking reality is that those who could benefit from drugs like lecanemab don’t have time to wait.”
She added: “Lecanemab represents the beginning of a sea-change in how diseases like Alzheimer’s will be treated in future.
“There are now more than 160 trials underway testing over 125 experimental treatments for Alzheimer’s across the globe, including 30 in late-stage trials.
“Despite today’s frustrating news, it really is a matter of when, not if, new treatments become available.
“What people living with Alzheimer’s disease – and other forms of dementia – desperately need are new medicines that improve their lives and Alzheimer’s Research UK will work tirelessly on behalf of people affected by dementia to ensure they get them.”
