A drug that can slow the debilitating symptoms of Alzheimer’s has been approved by the medicines regulator.
In an unusual double-header assessment by authorities, the Medicines and Healthcare products Regulatory Agency (MHRA) has said the drug lecanemab is safe and effective enough for doctors to prescribe in Britain, but a separate NHS watchdog has ruled that it’s not cost-effective and won’t be available.
The decision by the National Institute for Health and Care Excellence (NICE) means that the first drug to show an effect in Alzheimer’s will only be available privately.
But it can also cause swelling and bleeding in the brain of some patients.
NICE heard evidence it slows down progression of the disease by between four and six months but concluded that the costs of providing the treatment, including fortnightly infusions in hospital and intensive monitoring for side effects, combined with the relatively small benefits it provides to patients, means it cannot be considered good value for the taxpayer.
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Dr Samantha Roberts, chief executive of NICE, said: “This is a new and emerging field of medicine which will no doubt develop rapidly.
“However, the reality is that the benefits this first treatment provides are just too small to justify the significant cost to the NHS. It is an intensive treatment to give to patients involving a hospital visit every two weeks with skilled staff needed to monitor them for signs of serious side effects, plus the cost of purchasing the drug.
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“Our independent committee has rigorously evaluated the available evidence, including the benefit for carers but NICE must only recommend treatments that offer good value to the taxpayer.”
The MHRA decision would not apply in Northern Ireland, which has a separate process.
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From November 2022: Inside a lab working on Alzheimer’s treatment
While US authorities have approved the drug, the EU’s medical regulator rejected a licence because it considered the benefits too small to justify the risks.
According to results of the clinical trial published two years ago, the drug cleared clumps of a protein called amyloid – thought to be a key cause of the most common form of dementia – from patients’ brains.
It removed so much of the amyloid protein that the patients wouldn’t have had enough evidence of Alzheimer’s disease on their brain scans to actually qualify for entry to the trial.
The study strongly suggests the drug only starts to have a clinical effect once amyloid is reduced to low levels in the brain.
Results after 12 months of treatment suggested it was ineffective – but after 18 months, the effect was significant.
Doctors were optimistic at the time that continued treatment would lead to even better results.
Veterans are set to join the King for a VE Day tea party today as the prime minister has paid tribute to the “selfless dedication” of the war generation.
Among them will be a 99-year-old who took part in the D-Day landings and a 100-year-old woman who worked in the Special Operations Executive, known as Churchill’s Secret Army.
Director general of the Royal British Legion, Mark Atkinson, said the charity was “proud” to be taking a place “at the heart of these national celebrations and commemorations” on the 80th anniversary of the end of the Second World War.
He said it would be “one of our last opportunities as a nation to pay tribute to those veterans still with us today”.
Evacuees from World War Two and veterans who were still in active conflict after VE Day are among the other guests set to attend the tea party, which will take place in the presence of the King and other members of the Royal Family.
Image: The Royal Family will watch a military procession and flypast on Monday. File pic: PA
At 12pm, the Royal Family will observe a military procession, followed by a flypast.
It will be the first major VE Day anniversary without any of the royals who stood on the balcony of Buckingham Palace on the day victory in Europe was declared, after the death of the late Queen Elizabeth II in 2022.
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‘Not just for Britain’
The celebrations come as Prime Minister Sir Keir Starmer praised veterans for their “selfless dedication” and thanked them for a “debt that can never fully be repaid” in an open letter ahead of VE Day.
He said the stories which will be heard this week from those who fought in the Second World War would be a reminder that the victory “was not just for Britain” but was also “a victory for good against the assembled forces of hatred, tyranny and evil”.
Sir Keir said the WW2 veterans “represent the best of who we are” and that without their service “the freedom, peace and joy that these celebrations embody, would not be possible”.
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VE Day veteran tells Sky News what the atmosphere was like when WWII was finally declared over in Europe
Personnel from NATO allies the US, France and Germany will be among those taking part in the procession in London.
The commemorations will begin with the words of Sir Winston Churchill‘s 1945 victory speech, spoken by actor Timothy Spall.
Thousands of people are expected to line the streets of the capital to witness the celebrations.
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On the anniversary itself on Thursday, marking exactly 80 years since the Allies formally accepted Germany’s surrender, a service of commemoration will be held at Westminster Abbey, to include a national two minutes’ silence.
Pubs across England and Wales, which usually close at 11pm, will also stay open for an extra two hours to allow punters more time to celebrate.
Eight men have been arrested by the Metropolitan Police in two unconnected but “significant” terrorism investigations.
In one operation on Saturday, counter-terror officers arrested five men – four of whom are Iranian nationals – as they swooped in on various locations around the country. All are in police custody.
The Met said the arrests related to a “suspected plot to target a specific premises”.
In an update shortly after midnight, the force said: “Officers have been in contact with the affected site to make them aware and provide relevant advice and support, but for operational reasons, we are not able to provide further information at this time.”
Commander Dominic Murphy, head of the Met’s Counter Terrorism Command, said: “Counter-terrorism policing, supported by police and colleagues from across the country, have conducted arrests in two really significant operations, both of which have been designed to keep the public safe from threats.
“There are several hundred officers and staff working on this investigation, and we will work very hard to ensure we understand the threats to the wider public.”
He refused to say if the plot was related to Israel, but described it as “certainly significant” and said “it is unusual for us to conduct this scale of activity”.
He also asked the public to “avoid speculation and some of the things that are being posted online”.
MI5 director general Ken McCallum said in October that the intelligence agency had responded to 20 “potentially lethal” Iran-backed plots since 2022. He warned of the risk of an “increase or broadening of Iranian state aggression in the UK”.
Rochdale resident Kyle Warren, who witnessed one of the arrests at a neighbouring house, said his children had been playing in the garden when they came running into the house, saying a man in a mask had told them to go inside.
“Obviously, I was a bit worried,” Mr Warren told Sky News’ Lisa Dowd, and so he went into the garden to investigate.
“As we’ve come out, we just heard a massive bang, seen loads of police everywhere with guns, shouting at us to get inside the house.”
Image: Kyle Warren said his children were ‘petrified’
From upstairs in his house, he then heard “loads of shouting in the house” and saw a man being pulled out of the back of the house, “dragged down the side entry and thrown into all the bushes and then handcuffed”.
There were about 20 to 30 officers with guns, he believes.
“It’s just shocking, really. You don’t expect it on your doorstep.”
His daughters were “petrified… I don’t think they’ve ever seen a gun, so to see 20 masked men with guns running round was quite scary for them”.
Mr Warren, who only moved into his house a year ago, said he had “never really seen anyone going in or out” of the house and actually thought it was empty.
Image: One suspect was arrested in Cheadle Hulme, Greater Manchester. Pic: Sarah Cash
Image: One suspect was arrested in Cheadle Hulme, Greater Manchester. Pic: Sarah Cash
Arrests and searches around the country
The Met added officers were carrying out searches at a number of addresses in the Greater Manchester, London and Swindon areas in connection with the investigation.
It said those detained were:
• A 29-year-old man arrested in the Swindon area • A 46-year-old man arrested in west London • A 29-year-old man arrested in the Stockport area • A 40-year-old man arrested in the Rochdale area • A man whose age was not confirmed arrested in the Manchester area.
Image: A 29-year-old man was arrested in the Stockport area
Terror arrests in separate investigation
Police also arrested three further Iranian nationals in London on Saturday as part of another, unrelated counter-terror investigation.
The suspects were detained under section 27 of the National Security Act 2023, which allows police to arrest those suspected of being “involved in foreign power threat activity”.
Home Secretary Yvette Cooper said: “These were two major operations that reflect some of the biggest counter state threat and counter terrorism operations that we have seen in recent years.
“This reflects the complexity of the kinds of challenges to our national security that we continue to face.”
Earlier, she thanked police and security services in a statement, and called the incidents “serious events that demonstrate the ongoing requirement to adapt our response to national security threats”.
Last year, the government placed the whole of the Iranian state – including its intelligence services – on the enhanced tier of the new foreign influence registration scheme.
It means anyone asked by Iran to carry out actions for the state must declare it, or face prison time.
And that comes in the context of increased warnings from government and the security services about Iranian activity on British soil.
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Counter terror officers raid property
Last year, the director general of MI5, Ken McCallum, said his organisation and police had responded to 20 Iran-backed plots presenting potentially lethal threats to British citizens and UK residents since January 2022.
He linked that increase to the ongoing situation in Iran’s own backyard.
“As events unfold in the Middle East, we will give our fullest attention to the risk of an increase in – or a broadening of – Iranian state aggression in the UK,” he said.
The implication is that even as Iran grapples with a rapidly changing situation in its own region, having seen its proxies, Hezbollahin Lebanon and Hamas in Gaza, decimated and itself coming under Israeli attack, it may seek avenues further abroad.
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The government reiterated this warning only a few weeks ago, with security minister Dan Jarvis addressing parliament.
“The threat from Iran sits in a wider context of the growing, diversifying and evolving threat that the UK faces from malign activity by a number of states,” Jarvis said.
“The threat from states has become increasingly interconnected in nature, blurring the lines between: domestic and international; online and offline; and states and their proxies.
“Turning specifically to Iran, the regime has become increasingly emboldened, asserting itself more aggressively to advance their objectives and undermine ours.”
As part of that address, Jarvis highlighted the National Security Act 2023, which “criminalises assisting a foreign intelligence service”, among other things.
So it was notable that this was the act used in one of this weekend’s investigations.
The suspects were detained under section 27 of the same act, which allows police to arrest those suspected of being “involved in foreign power threat activity”.