The first drug to clearly slow the progression of Alzheimer’s disease has been fully approved in the US, with a UK decision ‘in the pipeline’.
Regulators have given full approval to lecanemab – also known as Leqembi – in a move hailed as a “major step forward” in the fight against the disease.
The decision was based on data from nearly 1,800 patients, which showed that the treatment slowed cognitive and functional decline by 27 percent over 18 months.
This is the equivalent of a five-month delay in disease progression, scientists said.
The drug, manufactured by the pharmaceutical company Eisai in Tokyo and Biogen in Cambridge, Massachusetts, is administered intravenously every other week.
Regulators have given full approval to lecanemab – also known as Leqembi – in a move hailed as a ‘major step forward’ in the fight against the disease (stock image)
It’s for early-stage Alzheimer’s patients with mild cognitive impairment or early dementia caused by Alzheimer’s, and a confirmed buildup of amyloid — a protein associated with dementia — in their brain.
The decision marks the first time in 20 years that an Alzheimer’s disease drug has received full approval, meaning the U.S. Food and Drug Administration (FDA) concluded there is solid evidence of a potential benefit.
However, the drug will come with a ‘boxed warning’ as it can cause brain bleeding and swelling.
An extended portion of the drug’s main study recorded three patient deaths believed to be related to the drug.
About 21 percent of the trial participants who received the drug experienced brain swelling or bleeding, compared with 9 percent of those who received a placebo.
The boxed warning also says that patients with two copies of a genetic variant that increases the risk of developing Alzheimer’s disease appear to be at a higher risk of complications.
Therefore, genetic testing – if possible – should take place before a patient receives the drug, the warning reads.
The news has been applauded by experts, with a similar approval process currently underway in the UK.
Hilary Evans, chief executive at Alzheimer’s Research UK, said: ‘This welcome news from the US is a step towards a world where Alzheimer’s is treatable, but should also serve as a wake-up call.
?Today’s ruling involved a 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 have written to the MHRA to urge them to complete this review as a matter of urgency, without compromising on quality, so that people living with Alzheimer’s in the UK are not left in the dark.
?We believe that a prompt regulatory decision on lecanemab will further strengthen the UK’s international reputation as a leader in dementia, attract even greater commercial investment in clinical trials in the UK and ultimately benefit an the two of us who will develop dementia in the future, or care for someone who has it.
About 21 percent of the trial participants who received the drug experienced brain swelling or bleeding, compared to 9 percent of those who received a placebo (stock image)
“With a UK decision on the horizon, today’s news underscores the urgency to get the NHS ready for new drugs such as lecanemab.”
Professor David Curtis from University College London Genetics Institute said: ‘This is truly remarkable news.
‘Certainly there are concerns about serious side effects and questions about the balance between clinical benefits and total treatment costs.
“Nevertheless, this decision marks Alzheimer’s as a disease that can potentially be treated or prevented, rather than simply endured.”
In 2021, another Alzheimer’s drug called aducanumab received “Accelerated Approval” in the US, meaning it can be prescribed to people who can afford it or who have the right medical coverage.
However, there is still debate over whether it shows ‘meaningful clinical benefit’ and full approval has yet to be given.