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Husband calls for change to law after wife’s dementia diagnosis
It will give hope to millions of sufferers by being the only treatment to target the deadly disease rather than mask its harrowing symptoms. Scientists believe that the drug aducanumab could mark a turning point in the fight against one of the gravest health crises of our age. And it paves the way for the treatment to be prescribed on the NHS after British regulators rule on its safety in the autumn.
Professor Bart De Strooper, director of the UK Dementia Research Institute, said: “The decision to approve aducanumab marks a hugely significant milestone in the search for much-needed treatments for Alzheimer’s.
“With no effective therapies currently available to modify the progression of this devastating disease we all hope it proves a turning point for the millions of people living with the condition.”
Aducanumab targets amyloid, the toxic plaque accumulating in the brains of those struck down with Alzheimer’s, helping slow the onset of the condition.
It is hoped it will help sufferers live longer, healthier and happier lives.
The drug, made by Biogen, will be sold under the brand name Aduhelm. It has been approved by the US Food and Drug Administration.
Around 1.5 million Americans will now be eligible for the new drug, which is given by infusion.
The UK Medicines and Healthcare Products Regulatory Agency, the same body that approved the world’s first Covid vaccines, will rule on its effectiveness later this year.
Aducanumab targets the toxic plaque accumulation in the brains of those struck down with Alzheimer’s (Image: Getty)
Last night, Alzheimer’s Research UK wrote to Health Secretary Matt Hancock demanding the process is accelerated.
Hilary Evans, the charity’s chief executive, said: “The decision marks a pivotal moment in the search for lifechanging new treatments for Alzheimer’s disease.
“The approval is a positive step forward for people with early Alzheimer’s and we welcome the opportunity for Biogen to conduct a post-approval clinical trial to reveal more about the potential real-world benefits of aducanumab.
“It will be the first ever drug to reach patients that tackles the underlying disease process itself. The findings of these additional studies could pave the way for a new generation of life-changing drug treatments.”
In the UK there are now more than 850,000 people living with dementia. But the race to find an effective cure comes as estimates forecast two million will be struck down by 2050.
Aducanumab’s approval signals the biggest breakthrough since the condition was discovered in 1906.
The therapy was designed to treat early onset but in 2019 Biogen said a major trial had been a failure and its programme was scrapped.
Matt Hancock has been asked to accelerate the approval of the drug (Image: Getty)
However, scientists restudied data from two final-stage trials of more than 3,000 patients, where some were treated with the highest dose, and found a statistically significant slowing of decline in cognitive ability.
Results of the experimental drug were described as “transformative”.
Early US clinical trials indicated it slowed mental decline in patients given doses at an early stage by as much as 22 per cent after 18 months.
Despite tens of billions of pounds of investment, no disease-altering drug has been shown to stop or reverse the condition, until now.
Yesterday’s announcement follows a string of crushing disappointments in Alzheimer’s drug development with at least nine major late-stage clinical trials failing in the last decade alone. Last November, the FDA’s
Peripheral and Central Nervous System Drugs Advisory Committee voted against approval of aducanumab over concerns the evidence did not support its effectiveness.
In yesterday’s ruling the FDA said it will assess further evidence of benefits in the post-approval clinical trial and as greater numbers of people receive the treatment. Aducanumab is a monthly antibody infusion that destroys the build-up of plaques.
In the UK there are now more than 850,000 people living with dementia (Image: Getty)
Tests showed a higher dose reduced the build-up of amyloid plaques and reduced cognitive decline.
Alzheimer’s patients experienced “significant benefits” in memory function, orientation and language and were better able to complete everyday tasks like cleaning, shopping and travelling independently.
Shares in Biogen rocketed after the news was announced.
UK dementia researchers have been battling to come up with a “disease modifying” dementia therapy by 2025. But they say their efforts have been thwarted because the Government has failed to honour a pre-election funding promise.
Mr Hancock had told the Daily Express he would double the amount of research cash in the hope of finding a cure, saying the UK would spend a total of £1.6billion over the next decade – an extra £83million a year. But his promise has yet to be honoured. Dr
Richard Oakley, head of research at Alzheimer’s Society, said: “We await the opinion of the EMA and the outcome of any application made to the UK regulatory authorities to give clarity to people with early Alzheimer’s.
“Whatever the outcome this is just the beginning of the road to new treatments.”
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