A “GAME-CHANGER” Alzheimer’s drug has been approved in the United States, slowing mental decline by up to 60 percent.
Donanemab, sold in the US under the brand name Kisunla, will be available for patients with early symptoms of the disease.
The drug remains under review by the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA).
A decision is expected in the coming months.
Samantha Benham-Hermetz, Executive Director of Policy and Communications at Alzheimer’s Research UK, said: “Today’s decision by the US regulators marks another important milestone in the global effort to tackle dementia.
“We hope to have a decision on the UK later this year.”
Donanemab, made by pharmaceutical company Eli Lilly, is an antibody-based treatment designed to remove amyloid – one of the characteristic proteins that accumulates in the brains of people with Alzheimer’s disease.
It is administered once a month as an infusion into the arm.
Clinical studies found it removed toxic proteins from patients’ brains and slowed mental decline by up to 60 percent within 18 months.
It was most effective in people in the earliest stages of Alzheimer’s disease – the leading cause of dementia – slowing the decline by an average of 36 per cent.
Among all participants, donanemab treatment reduced amyloid plaque by an average of 84 percent after 18 months, compared with a one percent decrease in placebo participants.
The US Food and Drug Administration (FDA) will offer donanemab to patients with early symptomatic Alzheimer’s disease.
This includes people with mild cognitive impairment (MCI), as well as those with a mild stage of Alzheimer’s disease dementia, with confirmed amyloid pathology.
If prescribed, doctors must monitor for side effects such as brain swelling, known as amyloid-related imaging abnormalities (ARIA), and infusion-related reactions.
Patients who have two APOE4 genes, associated with a higher risk of Alzheimer’s disease, are more likely to develop ARIA than those with only one copy or those who are not carriers.
The FDA recommends testing for APOE4 status before starting treatment.
Anne White, executive vice president of Eli Lily, said: “Kisunla has shown very significant results in people with early symptomatic Alzheimer’s disease.
“This brings hope to people who urgently need new treatment options.
“We know that these drugs have the greatest potential benefit when people are treated at earlier stages of the disease, and we are working hard with others to improve detection and diagnosis.”
While drugs like donanemab are a promising start, we need to go further
Samantha Benham-Hermetz
Fiona Carragher, director of research and advocacy at the Alzheimer’s Society, added: “This is another step forward in the fight against dementia, the biggest health and social challenge of our time.
“But there are still many hurdles before donanemab will be available on the NHS.”
While Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis, said, “I’m excited to have different options to help my patients.
“As a dementia specialist, it was difficult – I diagnose my patients with Alzheimer’s and then every year I see them deteriorate and progress to death.”
What do British experts say?
Samantha Benham-Hermetz, Executive Director of Policy and Communications at Alzheimer’s Research UK, said:
“Today’s decision by US regulators marks another important milestone in the global effort to tackle dementia.
“Donanemab is built on decades of scientific discovery and is one of the first drugs to be shown to be effective in slowing the destructive course of Alzheimer’s disease.
“There is still some way to go before donanemab reaches patients in the UK.”
“It is important that the Medicines and Healthcare Products Regulatory Agency (MHRA) independently looks at the full clinical trial data to ensure that the benefits of donanemab outweigh the risks for people living with early Alzheimer’s in the UK and that the treatment is safe . and clinically effective.
“We hope that the decision will be made this year.
“While drugs like donanemab are a promising start, we need to go further.
“As with many first-generation treatments, the benefits of donanemab are modest and come with the risk of serious side effects.
“It’s only used to treat people with early Alzheimer’s disease, which means most people living with dementia will unfortunately not benefit from it.
“The next Government must champion the work of Dame Barbara Windsor’s Dementia Mission to ensure the health system is ready to lead the rollout of innovative new Alzheimer’s drugs and help accelerate research to bring us closer to cures for all forms of the disease. dementia.
“The outlook for people with dementia is finally changing and it is more important than ever that the UK is a global leader in accelerating progress.”
In Alzheimer’s disease, two key proteins, tau and amyloid beta, accumulate into tangles and plaques, collectively known as aggregates, which cause brain cells to die and lead to brain shrinkage.
Donanemab is the second drug that has been shown to prevent and reverse this process.
It is followed by lecanemab, whose results showed a 27 percent slowdown in decline last year.
Around 900,000 Britons suffer from dementia, with Alzheimer’s responsible for two out of three cases. It is the UK’s biggest killer.
Cases are increasing, still with no hope of a cure, as current drugs can only alleviate symptoms.
The MHRA is deciding whether the two medicines are safe and effective enough to be available in the UK.
The National Institute for Health and Care Excellence (NICE) will then consider whether they should be offered on the NHS.
Medicines can cause serious side effects, including death, do not work for all patients, and are likely to be very expensive.
Experts also warn that the NHS does not yet have enough capacity or brain scanners to roll them out to everyone who could benefit.
What are the first signs of cognitive decline?
We all experience a natural decline in memory and thinking as we age.
For some people it will be more pronounced because they have memory and thinking problems that are mild but still noticeable.
This is described as mild cognitive impairment (MCI). Unlike people with dementia, people with MCI can still carry on with their daily lives.
Research suggests that two out of 10 people are elderly
in 65 have MCI, according to Alzheimer’s Research UK.
About one in 10 people diagnosed with MCI will develop dementia.
Symptoms of MCI include:
Memory – Misplacement of items or trouble
recalling recent conversations.
- Attention problems – it is difficult to concentrate,
eg while watching a TV program or performing
duties - Disorientation – Confusion about time, date or place
- Thinking skills – trouble planning or finishing
tasks such as managing money or cooking - Problems with communication and finding the right words
- Changes in mood and behavior – irritability, anxiety,
or feeling low
These symptoms can affect someone with MCI
time, or they may come and go.
There are steps we can take to keep our brains as healthy as possible. These include:
- No smoking
- Performing regular physical activity
- Stay mentally and socially active
- Eat a healthy balanced diet
- Limiting the amount of alcohol we drink
- Have your hearing checked regularly
- Maintaining blood pressure, blood sugar and cholesterol
levels under control