The first ever drug shown to work against Alzheimer’s could be available on the NHS by next year.
Aducanumab, if confirmed to slow mental decline, could be approved in the US next week.
Alzheimers affects one million Brits and killed legend Barbara Windsor. Alzheimer’s Research UK said: “There’s huge hope now.”
Millions of Alzheimer’s sufferers have been given fresh hope as the US is set to approve the new breakthrough drug within days.
If found to work by US regulators it would signal one of the biggest breakthroughs since the disease was discovered in 1906.
Clinical trial data is being analysed to see whether Aducanumab slows the decline in memory and thinking skills.
Early results indicated it slowed mental decline in patients given it at an early stage by 22% after 18 months.
A landmark approval decision by the Food and Drug Administration would indicate UK regulators could also give the drug the green light by Autumn and be offered on the NHS as soon as 2022.
Despite billions of pounds of investment over decades, until now no disease-altering drug has been shown to stop or reverse its progression.
The only drugs available can temporarily alleviate symptoms in some patients and the last one of these was developed 17 years ago.
Aducanumab, developed by US firm Biogen, targets a toxic protein that builds up in the brains of Alzheimer’s patients called amyloid.
Dr Susan Kohlaas, director of research at Alzheimer’s Research UK, told the Mirror: “There is huge hope in dementia research now.
“It’s really important that we start to see the first disease modifying therapies for dementia come through.
“This could be a really important step in changing the whole research field.”
More than 50 million people worldwide are living with dementia and this is expected to almost double every 20 years.
Alzheimer’s disease is the most common cause of dementia and may contribute to 60 to 70% of cases.
Dementia itself is a syndrome in which there is deterioration in memory and thinking and around one million Brits have the condition.
It is estimated to cost the UK economy £26 billion a year – more than cancer and heart disease combined.
There has long been debate about what causes the disease but those who die from it have tangles of sticky amyloid plaques in their brains.
Aducanumab uses an artificially created antibody, which is designed to latch on to amyloid plaques and destroy them.
Trials were initially stopped last year when statistical analyses suggested that it was having no effect.
But in October last year Biogen reversed that position, claiming that a larger dataset showed that in patients with the first symptoms who received a very high dose, it slowed their mental decline.
US regulators have been analysing its extended datasets ever since and their much anticipated conclusion will come within days.
Dr Kohlaas has called on the UK regulator to fast track it review of Aducanumab like it did with Covid-19 vaccines.
If granted Medicines and Healthcare products Regulatory Agency approval, then NICE could take around a year before deciding whether to provide the drug for free on the NHS.
Existing drugs such as Aricpet increase the communication between remaining healthy nerve cells in the brain. Other existing drugs include Reminyl, Exelon and Memantine.
Dr Kohlaas said: “They can help with stabilizing memory loss but unfortunately they don’t work for everyone and over time their effects wear off.
“They do help on a day to day basis and for people it can be hugely helpful for people managing their symptoms. But these drugs don’t slow down the memory loss over time that we see in dementia.”
Options available to the FDA are to reject Aducanumab, approve the drug, or issue a conditional approval with a requirement to collect more data through a new clinical trial.
It comes after more than 200 multi-million pound trials of drugs to tackle Alzheimer’s have failed or been abandoned in the last decade.
“There have been a number of high profile disappointments,” Dr Kohlaas admitted.
“Of course it’s disappointing to have treatments go through clinical trials that don’t work but that’s why we need more research.”
Bestselling children’s author Sir Terry Pratchett was diagnosed with early onset Alzheimer’s in 2007 and campaigned to break stigma around the disease for nine years until his death aged just 66.
Other pubic figures to be diagnosed with the devastating disease include actress Barbara Windsor, actor Robin Williams, ex-PM Margaret Thatcher and former US President Ronald Reagan.
Despite fears Covid-19 has led to a ‘brain drain’ of researchers away from dementia, the pandemic has also sparked optimism for the future.
Dr Kohlaas explained: “We are hopeful that we can cure the diseases that cause dementia and I think with justification.
“With the right investment and focus we can do that.
“We can learn so much from Covid. Just seeing the impact that bringing together the research community with a real focus and prioritisation from Government, that you can make a big impact in a short space of time.”