A “revolutionary” Alzheimer’s drug that slows mental decline by up to 60% has been approved in the United States.
Donanemab, commercially known as Kisunla, will be available to patients with early symptoms of the disease.
The medicine continues to be considered by the British regulator, 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 regulators in the US marks another important milestone in the global effort to combat dementia.
“We are hopeful that a decision will be made later this year for Britain.”
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.
It is administered as an infusion into a person’s arm once a month.
Clinical trials found that it eliminated toxic proteins from patients’ brains and slowed mental decline by up to 60% over 18 months.
It was most effective for people in the early stages of Alzheimer’s disease – the main cause of dementia – and slowed the decline by 36 percent on average.
Among all participants, donanemab treatment reduced amyloid plaque by an average of 84% at 18 months, compared with a 1% reduction in participants taking placebo.
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 mild dementia stage of Alzheimer’s disease with confirmed amyloid pathology.
When prescribed, doctors must monitor for side effects such as brain swelling, known as amyloid-related imaging abnormalities (ARIA), and infusion-related reactions.
Patients who carry two APOE4 genes, associated with a higher risk of Alzheimer’s, are more likely to develop ARIA than those with just one copy or non-carriers.
The FDA recommends testing APOE4 status before starting treatment.
Anne White, Executive Vice President of Eli Lily, said: “Kisunla has demonstrated very significant results for people with early symptomatic Alzheimer’s disease.
“This brings hope to people who urgently need new treatment options.
“We know that these medicines have the greatest potential benefit when people are treated at an early stage of the disease, and we are working hard in partnership 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 influencing at the Alzheimer’s Society, added: “This marks another step forward in the fight against dementia, the biggest health and social care challenge of our time.
“But there are still many hurdles before donanemab can be available on the NHS.”
While Dr Suzanne Schindler, a neurologist at Washington University in St Louis, said: “I am thrilled to have different options to help my patients.
“It’s been difficult as a dementia specialist – I diagnose my patients with Alzheimer’s disease and every year I watch them get worse and progress until they die.”
What do UK 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 combat dementia.
“Donanemab is based on decades of scientific discoveries and is one of the first medicines proven to slow the destructive course of Alzheimer’s disease.
“There is still a long way to go before donanemab can reach patients in Britain.
“It is important that the Medicines and Healthcare products Regulatory Agency (MHRA) independently reviews the full clinical trial data to ensure that the benefits of donanemab outweigh the risks for people living with early-onset Alzheimer’s disease. Great Britain, and that the treatment is safe and clinically effective.
“We hope a decision will be made later 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 carry a risk of serious side effects.
“It is only used to treat people with early-stage Alzheimer’s disease, which means that, unfortunately, most people living with dementia will not benefit.
“The next government must boost the work of the Dame Barbara Windsor Dementia Mission, to ensure the healthcare system is ready to lead the adoption of innovative new medicines for Alzheimer’s disease and help accelerate research that will bring us closer to a cure for Alzheimer’s disease. all forms of Alzheimer’s disease. insanity.
“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 in tangles and plaques, known together as aggregates, that cause brain cell death and lead to brain shrinkage.
Donanemab is the second medication proven to prevent and reverse this process.
This is followed by lecanemab, whose results last year showed a slow decline of 27 percent.
Around 900,000 Britons have dementia, with Alzheimer’s disease responsible for two in three cases. He is the UK’s number one killer.
Cases are increasing, with no hope of a cure yet, as current medications can only reduce symptoms.
The MHRA is deciding whether the two medicines are safe and effective enough to be used on the NHS.
They can cause serious side effects, even death, do not work for all patients, and are likely to be very expensive.
Experts also warn that the NHS does not yet have the capacity or enough brain scanners to distribute them to everyone who could benefit.
two
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 have memory and thinking problems that are mild but still noticeable.
This is described as mild cognitive impairment (MCI). Unlike people who suffer from dementia, people with MCI can still go about their daily lives.
Research suggests that two in 10 people over the age
of 65 have MCI, according to Alzheimer’s Research UK.
About one in 10 people who receive an MCI diagnosis will develop dementia.
Symptoms of MCI include:
Memory – Losing items or having problems
remembering recent conversations.
- Attention problems – difficulty concentrating,
for example, while watching a TV program or performing
job duties - Disorientation – confusion about time, date or location
- Thinking Skills – Problems with Planning or Completion
tasks, for example managing money or cooking a meal - Problems with communication and finding the right words
- Changes in mood and behavior – becoming irritable, anxious,
or feeling depressed
These symptoms can affect someone with MCI all the time
time, or they may come and go.
There are steps we can take to keep our brains as healthy as possible. These include:
- Do not smoke
- Do regular physical activity
- Stay mentally and socially active
- Eat a healthy and balanced diet
- Limit the amount of alcohol we drink
- Checking your hearing regularly
- Maintain blood pressure, blood sugar and cholesterol
levels in check
This story originally appeared on The-sun.com read the full story
/cdn.vox-cdn.com/uploads/chorus_asset/file/25521968/Affinity_six_month_free_trial.jpg?w=300&resize=300,300&ssl=1 "Affinity’s Adobe-rival creative suite is now free for six months")
/cdn.vox-cdn.com/uploads/chorus_asset/file/23932925/acastro_STK108__03.jpg?w=300&resize=300,300&ssl=1 "Epic says its EU iOS app store is approved, but Apple wants a change")
