A groundbreaking Alzheimer’s drug has been approved in the United States that slows mental decline by up to 60 percent.
Donanemab, sold in the US under the brand name Kisunla, is available for patients with early symptoms of the disease.
The drug is still under review by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
A decision is expected in the coming months.
Samantha Benham-Hermetz, director of policy and communications at Alzheimer’s Research UK, said: “Today’s decision by US regulators marks another important milestone in the global fight against dementia.
“We hope that a decision will be made for Britain later this year.”
Donanemab, produced by pharmaceutical company Eli Lilly, is an antibody-based treatment designed to remove amyloid, one of the main proteins that builds up in the brains of people with Alzheimer’s.
It is administered once a month through an IV in the arm.
Clinical trials have shown it removes toxic proteins from patients’ brains and slows mental decline by 60 percent over 18 months.
It was most effective in people in the earliest stages of Alzheimer’s disease, the leading cause of dementia, slowing decline by an average of 36 percent.
In all participants, treatment with donanemab resulted in an average reduction of amyloid plaque by 84 percent after 18 months, compared with a one percent reduction in participants who received a placebo.
The US Food and Drug Administration (FDA) will offer donanemab to patients with early symptomatic Alzheimer’s disease.
This applies to people with mild cognitive impairment (MCI) and to people with the mild dementia phase of Alzheimer’s disease, in whom amyloid pathology has been confirmed.
When this medicine is prescribed, doctors should watch for side effects such as swelling of the brain (known as amyloid-related imaging abnormalities (ARIA)) and infusion-related reactions.
Patients with two APOE4 genes, which are associated with a higher risk of Alzheimer’s, are more likely to develop ARIA than patients with only one copy or patients who are not carriers.
The FDA recommends testing APOE4 status before starting treatment.
Anne White, executive vice president at Eli Lily, said: “Kisunla showed very meaningful results for people with early symptomatic Alzheimer’s disease.
“This gives hope to people who urgently need new treatment options.
“We know that these drugs have the greatest potential when people are treated early in their disease, so 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 greatest health and social care challenge of our time.
“But there are still many hurdles before donanemab can be available on the NHS.”
Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis, said, “I’m glad I have different options to help my patients.
“As a dementia specialist, it’s tough. I diagnose my patients with Alzheimer’s disease and every year I see their condition get worse and worse until they die.”
What do the 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 fight against dementia.
“Donanemab is based on decades of scientific discovery and is one of the first drugs proven effective in slowing the devastating progression of Alzheimer’s disease.
“There is still a long way to go before donanemab reaches patients in the UK.
“It is important that the Medicines and Healthcare products Regulatory Agency (MHRA) looks independently at the full clinical trial data to satisfy itself that the benefits of donanemab outweigh the risks for people with early Alzheimer’s in the UK, and that the treatment is safe and clinically effective.
“We hope that a decision will be made later this year.
“While drugs like donanemab are a promising start, we must go further.
“As with many first-generation treatments, the benefits of donanemab are modest and there is a risk of serious side effects.
“It is only used to treat people with early-stage Alzheimer’s disease. Unfortunately, most people with dementia will not benefit from it.
“The next government must continue the work of the Dame Barbara Windsor Dementia Mission, to ensure the health system is ready to lead the way in introducing innovative new medicines for Alzheimer’s, and to accelerate research that will bring us closer to a cure for all forms of dementia.
“The outlook for people with dementia is finally changing and it is more important than ever that the UK is a world leader in accelerating progress.”
In Alzheimer’s disease, two key proteins, tau and amyloid beta, build up into clumps and plaques, collectively called aggregates, causing brain cells to die and the brain to shrink.
Donanemab is the second drug proven to prevent and reverse this process.
This is a follow-up to lecanemab, which last year’s results showed a delayed decline of 27 percent.
Around 900,000 Britons have dementia, with Alzheimer’s accounting for two in three cases. It is the biggest killer in the UK.
The number of cases is increasing and there is still no hope for a cure, as current medications can only reduce symptoms.
The MHRA is investigating 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 assess whether they should be offered through the NHS.
The drugs can have serious side effects, sometimes even fatal, do not work in all patients and are likely to be very expensive.
Experts also warn that the NHS does not yet have sufficient capacity or brain scanners to make the technology available to everyone who could benefit from it.
What are the early symptoms of cognitive decline?
WE all notice that our memory and thinking skills naturally decline as we age.
In some people this is more the case, as they experience mild but noticeable memory and thinking problems.
This is described as mild cognitive impairment (MCI). Unlike people with dementia, people with MCI can still continue with their daily lives.
Research shows that two out of ten people over the age of 10
of 65 have MCI, according to Alzheimer’s Research UK.
About one in ten people diagnosed with MCI will develop dementia.
Symptoms of MCI include:
Memory – Losing things or having problems
remember recent conversations.
- Attention problems – having difficulty concentrating,
for example while watching a TV program or performing
tasks at work - Disorientation – confusion about time, date, or place
- Thinking skills – problems with planning or completing
tasks such as managing money or cooking a meal - Problems with communication and finding the right words
- Mood and behavior changes – becoming irritable, anxious,
or a depressed feeling
These symptoms can affect someone with MCI throughout the day
time, or they might come and go.
There are steps we can take to keep our brains as healthy as possible. These include:
- Do not smoke
- Engage in regular physical activity
- Staying mentally and socially active
- Follow a healthy and balanced diet
- Limit the amount of alcohol we drink
- Have your hearing checked regularly
- Keeping blood pressure, blood sugar and cholesterol under control
levels under control