The first drug to clearly slow the progression of Alzheimer’s has been fully approved in the US, with a UK decision ‘on the horizon’. 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 the treatment slowed cognitive and functional decline by 27 per cent over 18 months. This is the equivalent of a five-month slowdown in the progression of the disease, scientists said.
The drug, manufactured by the pharmaceutical company Eisai in Tokyo and Biogen in Cambridge, Massachusetts, is given intravenously every other week. It is for early-stage Alzheimer’s patients with mild cognitive impairment or early dementia caused by Alzheimer’s, and a confirmed build-up of amyloid – a protein linked to dementia – in their brains.
The decision marks the first time in 20 years that a drug for Alzheimer’s has received full approval, meaning that the US Food and Drug Administration (FDA) concluded there is solid evidence of a potential benefit.
The drug, however, will come with a ‘boxed warning’ because it can cause brain bleeding and swelling. In an extended portion of the drug’s main trial three patient deaths were recorded, thought to be linked to the drug.
Around 21 per cent of trial participants who received the drug experienced brain swelling or bleeding, compared to 9 per cent 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 appear to be at a higher risk of complications.
Therefore genetic testing should occur – if possible – before a patient receives the drug, the warning reads. The news has been hailed by experts while a similar approval process is currently underway in the UK.
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 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’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.’
Professor David Curtis, from the University College London 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.’
In 2021 a different Alzheimer’s drug, named aducanumab, was given ‘Accelerated Approval’ in the US, meaning it can be prescribed to people who can afford it or who have appropriate medical cover. However, there is still debate as to whether it shows ‘meaningful clinical benefit’ and has yet to be given full approval.