Lecanemab has been found to slow cognitive decline by 27% in sufferers. Photo / 123RF
Lecanemab has been found to slow cognitive decline by 27% in sufferers. Photo / 123RF
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% in sufferers.
On Thursday, the Medicines and HealthcareProducts Regulatory Agency (MHRA) isexpected 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 National Health Service (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.
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, that 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.”
The first drug found to slow down Alzheimer’s is to be given the green light for use in Britain. Photo / 123RF
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%.
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 US$45,000 ($75,000) 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% 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 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%,” 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.
