BREAKTHROUGH drug found to slow memory-robbing Alzheimer’s is a step closer to being approved for use in the UK.
It’s manufacturers announced this week they had submitted a marketing authorisation application to the Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s medicine watchdog.
Eisa and Biogen submitted lecanemab for MHRA approval
The innovative drug, named lecanemab, made headlines last year after tests on 1,800 patients found it cleared toxic protein clumps from the brain, staving off nerve damage and buying precious extra time to dementia sufferers.
An estimated 900,000 people in the UK live with dementia and there is currently no cure or effective treatment for the crippling condition.
But lecanemab received Food and Drug Administration approval in the US in January and could be greenlit for UK use under an accelerated pathway.
Pharma companies Eisa and Biogen said the MHRA had placed the drug under its Innovative Licensing and Access Pathway, which aims to cut down the time it takes for medicines to reach patients.
If approved, it could still take years for before NHS clinics can give it out and it’ll be expensive.
Trials for lecanemab showed that though it reduced Alzheimer’s-induced decline for many people, some experienced severe side effects including deadly brain bleeds.
The MHRA will have to weigh these up against the benefits.
Eisa and Biogen have been conducting an additional phase III clinical trial for lecanemab since July 2020.
Results from previous trials prompted Dr Susan Kohlhaas, of Alzheimer’s Research UK, to describe them as “a historic moment for dementia research”.
“This is the first drug that’s been shown to not only remove the build-up of a protein called amyloid in the brain, but to have a statistically significant impact on cognitive decline in people with early-stage disease,” she added.
Scientists have spent years trying to prove that reducing levels of a toxic protein called amyloid will slow Alzheimer’s and the study offered solid proof that it’s possible to remove it and that doing so eases dementia symptoms.
Eisai and Biogen gave one dose of lecanemab every two weeks to around 900 people with early-stage Alzheimer’s – and a placebo drug to another 900.
After 18 months, those given the real treatment had brain scores 27 per cent higher than patients given a fake medicine, proving their disease had slowed down.
Scans also revealed lower levels of amyloid protein in their brains.
Even though it cannot cure Alzheimer’s, this could buy patients precious months or even years of extra time before they lose their faculties.
Symtpoms of Alzheimer’s disease
Alzheimer’s disease can affect everyone differently and get worse over time.
Its causes are complex, but one key part is the build-up of two substances inside the brain called amyloid and tau, according to Alzheimer’s Society.
These clump up and form tiny structures called plaques and tangles that make it harder for the brain to work properly. Eventually the brain struggles to cope with the damage and the person begins to have problems with memory and thinking.
Common early symptoms of Alzheimer’s are:
memory problems
thinking and reasoning difficulties
language problems
changes to how they see and hear things
changes in mood
David Thomas, head of policy at Alzheimer’s Research UK, said: “We want to see the MHRA reach an evidence-based decision on lecanemab’s safety and efficacy as a matter of urgency.
“People [in the UK] with AD and their families deserve effective new treatments and, should lecanemab be approved, it would be the first new Alzheimer’s drug here for nearly 20 years.”