EUROPE has rejected a breakthrough Alzheimer’s drug in a blow to NHS hopes.
Lecanemab is one of the first medicines ever proven to destroy toxic amyloid proteins that build up in patients’ brains in early stages of the disease.
The European Medicines Agency ruled on Friday that the risk of serious or even fatal side effects is too great for it to be used.
Clinical trials saw the drug hailed a game-changer as it slowed brain damage by up to a third, but patients were in danger of stroke, brain swelling or shrinking, or death.
The EMA’s medicines committee said: “The observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious side events associated with the medicine.”
It recommended the drug should not be licensed, meaning European health services will not use it.
Europe tends to view the glass as half-empty
Professor Bart de Strooper
The decision splits off from the USA, which approved the drug last year and already prescribes it.
It casts doubt over hopes that Britain will wave through the medication for NHS use when our regulator decides later this year.
Last time Europe and the USA were divided on an Alzheimer’s drug – a similar one called aducanumab, in 2021 – the UK sided with Europe and never used it.
Professor Bart de Strooper, of the UK Dementia Research Institute, said today: “This is an unfortunate yet not unexpected decision.
“While countries such as the USA, China, and Japan see the glass as half-full, Europe tends to view it as half-empty.
“This conservative approach means that patients and doctors eager to explore a proven effective drug are now denied access.
“It is a sombre day for the patients who could have benefited from lecanemab and for the advancement of clinical research that has been stifled for too many years.”
Manufacturers to appeal the decision
Professor Jonathan Schott, chief medical officer at Alzheimer’s Research UK, said: “The EMA’s recommendation runs counter to the decision reached by other G7 nations like the US and Japan.
“Attention will now turn to the UK’s regulator – the MHRA – which is expected to announce a decision on lecanemab imminently.
“This announcement can’t come too soon for people with Alzheimer’s disease in Great Britain who, for now, must wait to see whether the UK will forge ahead with innovative medicines or follow the EMA and adopt a more cautious approach.
“While disappointing, today’s news is a reminder both of how far we have come, and how much work there still is to do.”
Dr John Hardy, of University College London, added: “I am disappointed in the decision.
“I am sure we will now see rich people with early Alzheimer’s disease flying to the US or other jurisdictions for treatment.
“My guess would be that this decision will be revisited.”
The drug manufacturers, pharmaceutical companies Eisai and Biogen, said they will appeal the ruling and call for a “re-examination”.
Dr Lynn Kramer, chief clinical officer at Eisai, said: “We are extremely disappointed by the negative opinion and understand that this may also be disappointing for the wider Alzheimer’s disease community.
“There is a significant unmet need for new treatment options.”
What are the early symptoms of cognitive decline?
WE all notice a natural decline in memory and thinking as we age.
This will be more pronounced in some people, as they experience memory and thinking problems that are mild but still noticeable.
This is described as mild cognitive impairment (MCI). Unlike dementia sufferers, people with MCI can still get on with day-to-day life.
Research suggests that two out of 10 people over the age
of 65 have MCI, according to Alzheimer’s Research UK.
About one in 10 people who’ve received an MCI diagnosis will go on to develop dementia.
Symptoms of MCI include:
Memory – Misplacing items or having trouble
remembering recent conversations.
- Attention problems – finding it difficult to concentrate,
e.g. while watching a TV programme or carrying out
duties at work - Disorientation – confusion about time, date or place
- Thinking skills – problems with planning or completing
tasks, e.g. managing money, or cooking a meal - Problems with communication and finding the right words
- Mood and behaviour changes – becoming irritable, anxious,
or feeling low
These symptoms may affect someone with MCI all the
time, or they might come and go.
There are steps we can take to keep our brains as healthy as possible. These include:
- Not smoking
- Doing regular physical activity
- Staying mentally and socially active
- Eating a healthy balanced diet
- Limiting the amount of alcohol we drink
- Having your hearing checked regularly
- Keeping blood pressure, blood sugar and cholesterol
levels in check
