First drug to SLOW Alzheimer’s lecanemab is approved in the US – as pressure mounts on UK to follow suit
A NEW drug which can slow the progression of Alzheimer’s has been approved for use in the US.
Lecanemab, known commercially as Leqembi, will be available for patients with mild dementia and other symptoms that appear in the early stages of the brain-robbing disease.
It is the first medicine that has shown to modestly slow cognitive decline.
Japanese drugmaker Eisai received conditional approval from the Food and Drug Administration (FDA) in January based on early results suggesting Leqembi worked by clearing a sticky brain plaque linked to the disease.
Following the 1,800-patient study, which found the drug slowed memory and thinking decline by 27 per cent over 18 months, it has now got the green light – mounting pressure on Britain to follow suit.
Hilary Evans, chief executive at Alzheimer’s Research UK, said: “This welcome news from the US signals a step towards a world where Alzheimer’s disease is treatable, but should also serve as a wake-up call.
“Today’s ruling involved careful review of data from a rigorous study of 1,800 patients.
“A similar process is currently underway in the UK, led by the Medicines and Healthcare products Regulatory Agency (MHRA).
“We’ve written to the MHRA urging them to complete this review as a matter of urgency, without compromising on quality, so people with Alzheimer’s in the UK aren’t left in limbo.
“We believe that a rapid regulatory decision on lecanemab will further strengthen the UK’s international reputation as a leader in dementia, attract even greater commercial investment in UK clinical trials, and ultimately benefit the one in two of us who will either develop dementia in the future, or care for someone who has it.
“With a UK decision on the horizon, today’s news underlines the urgency of getting the NHS ready for new medicines like lecanemab.”
FDA’s neurology drug director Teresa Buracchio said Leqembi was “safe and effective” but the packaging will carry the most serious type of warning as it can cause brain swelling and bleeding in rare cases.
A year’s supply of Leqembi costs around $26,500 (£20,000), although health insurers will negotiate that down.
It is administered by injection every two weeks.
Eisai told investors that about 100,000 Americans could be diagnosed and eligible to receive the medicine by 2026.
An application for marketing authorisation in the UK was filed in May, and a decision is expected by the end of the year.
Prof David Curtis, honorary professor at UCL Genetics Institute, said: “This really is remarkable news.
“Certainly there are concerns about serious side effects and questions about the balance between clinical benefits and the overall costs of treatment.
“Nevertheless, this decision badges Alzheimer’s disease as an illness which can potentially be treated or prevented, rather than simply endured.”
Alzheimer’s disease accounts for 60 to 80 percent of dementia, according to the Alzheimer’s Association.
It progressively destroys thinking and memory, eventually robbing people of the ability to carry out the simplest of tasks.
Some 6.7million people aged 65 and over suffer from the condition in the US, while around 900,000 are affected in the UK.
Early warning signs of dementia
- Short-term memory loss such as forgetting names and important dates and repeatedly asking the same questions
- Changes in behaviour – unexpected and uncharacteristic anxiety and changes in mood, perhaps becoming passive and disinterested, or easily angered
- Confusion which could include losing track of time or problems with processing information
- Forgetting words and experiencing problems with speech and language
- Loss of sense of direction, getting lost in a familiar environment and disorientated
- Difficulty in performing every day (seemingly normal) tasks such as making a cup of tea or unpacking the grocery shopping
- Problems with calculation – managing money or completing simple sums and puzzles may become an issue
- Misplacing items such as putting keys in freezer or milk in the dishwasher and not being able to retrace steps to find them
- Difficulty making decisions which may also include making the wrong decision such as personal grooming
- Issues with visual images and spatial awareness which may include difficulty reading words, judging distances or recognising colour contrast
Anyone over 50 experiencing two or more of these symptoms, which have been gradually progressing over the past 12 months, should see their GP.
Source: Brain and Mind Experts