A SECOND “game-changing” Alzheimer’s drug shown to slow the progression of the disease has been approved in the UK.
Donanemab, developed by pharmaceutical giant Eli Lilly, was today given the green light by the Medicines and Healthcare products Regulatory Agency.
The ruling means the drug is deemed safe and effective for people in the early stages of the disease and paves the way for patients to be prescribed the drug privately for the first time.
It’s a major step and comes after regulators in the US gave the drug the nod, and two months after a similar drug, lecanemab was approved for use in the UK.
But there are fears that like Lecanemab it might not be made available on the NHS, according to reports from The Telegraph.
The National Institute for Health and Care Excellence (NICE), which decides what drugs are available on the NHS, is expected to rule that the drug is too expensive for NHS patients, the newspaper reported.
The decision is expected to disappoint charities and campaigners who have called for better access to newly emerging drugs.
The advent of the two drugs has been hailed as the beginning of a “new era where it [Alzheimer’s] could become treatable”.
Donanemab is an antibody-based treatment that works by removing amyloid – a protein that builds up in the brains of people with Alzheimer’s.
Amyloid plaques have become a hallmark of the debilitating disease, which is the most common form of dementia.
The immunotherapy drug is given as an infusion into a person’s arm once a month.
Clinical trials have found it cleared these toxic proteins from patients’ brains and slowed mental decline by up to 60 per cent over 18 months.
It was found to be most effective in the earliest stages of the progressive disease, and slowed decline by 36 per cent on average.
In all those volunteers taking part in trials, donanemab reduced amyloid plaques on average by 84 per cent after 18 months.
That compared to a one per cent decrease for those taking a placebo.
It is estimated that 982,000 people in the UK live with dementia, and that number is expected to spiral to a staggering 1.4million by 2040, according to the Alzheimer’s Society.
Dementia and Alzheimer’s disease was the leading cause of death in the UK from 2012 to 2021. In 2022, it remained the leading cause of death in women, in England and Wales.
FIRST ‘GAME-CHANGER’ DRUG NOT AVAILABLE ON NHS
Lecanemab works in a similar way, helping to clear the build-up and slow cognitive decline.
The key difference is that while both target the amyloid proteins, they attack it at different stages.
Lecanemab targets amyloid as it begins to form fibres in the brain, while donanemab binds to the protein once the fibres have clumped together to become a plaque on the brain.
'My memory is much better than it was,' says one of the first patients to take lecanemab
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.”
Lecanemab is already licensed for use in the US, China, Japan, Hong Kong, South Korea and Israel.
But in July the European Medicines Agency rejected the drug, saying the benefits of lecanemab did not outweigh the risk of serious side effects, such as bleeding and swelling in the brain.
In the UK, lecanemab is now approved to treat adults in the early stages of Alzheimer’s who have one or no copies of the APOE4 gene.
But in a blow to patients, the National Institute of Health and Care Excellence (Nice) advised that “the benefits are too small to justify the cost”, so the drug won’t be available to patients on the NHS.
No price for the drug has been publicly announced, but in the US it costs around £20,000 a year per patient.
