London Daily

Focus on the big picture.
Friday, Aug 22, 2025

US approves first Alzheimer’s drug in decades

US approves first Alzheimer’s drug in decades

US government health officials have approved the first new drug for Alzheimer’s disease in nearly 20 years, paving the way for its possible use in the UK.

They did so while disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease.

The Food and Drug Administration said it granted approval to the drug from Biogen based on results that seemed “reasonably likely” to benefit Alzheimer’s patients.

It’s the only drug that US regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia.

Aducanumab targets amyloid, a protein that forms abnormal clumps in the brains of people with Alzheimer’s that can damage cells and trigger dementia.

The decision to approve it, which could impact millions of older Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups.

It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.

The new drug, which Biogen developed with Japan’s Eisai Co, did not reverse mental decline, only slowing it in one study.

The treatment could lead other pharmaceutical companies to create similar drugs and the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), to consider it for use in Britain.

At least 100,000 people in the UK with a mild form of the disease could be suitable for the drug if it were to be approved by the UK regulator, the BBC reported.

Alzheimer’s Research UK, said it had written to the Health Secretary Matt Hancock asking the government to prioritise the fast-track approval process for the drug in the UK.

Chief executive Hilary Evans, said: “People with dementia and their families have been waiting far too long for life-changing new treatments.

“It is now essential that regulatory authorities assess the evidence to decide whether they believe the drug is safe and effective for use in the UK.”

Alzheimer’s Society said the drug was "promising" but added it was "just the beginning of the road to new treatments for Alzheimer’s disease".

The medication, aducanumab, will be marketed as Aduhelm and is to be given as an infusion every four weeks.

Dr Caleb Alexander, an FDA adviser who recommended against the drug’s approval, said he was “surprised and disappointed” by the decision to approve it.

“The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. In this case, I think they gave the product a pass,” said Dr Alexander, a researcher at Johns Hopkins University.

The FDA’s top drug regulator acknowledged in a statement that “residual uncertainties” surround the drug, but said Aduhelm’s ability to reduce harmful clumps of plaque in the brain “is expected” to help slow dementia.

Under terms of the so-called accelerated approval, the FDA is requiring the drugmaker to conduct a follow-up study to confirm benefits for patients.

If the study fails to show effectiveness, the FDA could pull the drug from the market, though the agency rarely does so.

Nearly six million people in the US and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and basic daily tasks.

In the final stages of the disease, those afflicted lose the ability to swallow.

The global burden of the disease, the most common cause of dementia, is only expected to grow as millions more baby boomers progress further into their 60s and 70s.

Newsletter

Related Articles

0:00
0:00
Close
After 200,000 Orders in 2 Minutes: Xiaomi Accelerates Marketing in Europe
Ukraine Declares De Facto War on Hungary and Slovakia with Terror Drone Strikes on Their Gas Lifeline
Animated K-pop Musical ‘KPop Demon Hunters’ Becomes Netflix’s Most-Watched Original Animated Film
New York Appeals Court Voids Nearly $500 Million Civil Fraud Penalty Against Trump While Upholding Fraud Liability
Elon Musk tweeted, “Europe is dying”
Far-Right Activist Convicted of Incitement Changes Gender and Demands: "Send Me to a Women’s Prison" | The Storm in Germany
Hungary Criticizes Ukraine: "Violating Our Sovereignty"
Will this be the first country to return to negative interest rates?
Child-free hotels spark controversy
North Korea is where this 95-year-old wants to die. South Korea won’t let him go. Is this our ally or a human rights enemy?
Hong Kong Launches Regulatory Regime and Trials for HKD-Backed Stablecoins
China rehearses September 3 Victory Day parade as imagery points to ‘loyal wingman’ FH-97 family presence
Trump Called Viktor Orbán: "Why Are You Using the Veto"
Horror in the Skies: Plane Engine Exploded, Passengers Sent Farewell Messages
MSNBC Rebrands as MS NOW Amid Comcast’s Cable Spin-Off
AI in Policing: Draft One Helps Speed Up Reports but Raises Legal and Ethical Concerns
Shame in Norway: Crown Princess’s Son Accused of Four Rapes
Apple Begins Simultaneous iPhone 17 Production in India and China
A Robot to Give Birth: The Chinese Announcement That Shakes the World
Finnish MP Dies by Suicide in Parliament Building
Outrage in the Tennis World After Jannik Sinner’s Withdrawal Storm
William and Kate Are Moving House – and the New Neighbors Were Evicted
Class Action Lawsuit Against Volkswagen: Steering Wheel Switches Cause Accidents
Taylor Swift on the Way to the Super Bowl? All the Clues Stirring Up Fans
Dogfights in the Skies: Airbus on Track to Overtake Boeing and Claim Aviation Supremacy
Tim Cook Promises an AI Revolution at Apple: "One of the Most Significant Technologies of Our Generation"
Apple Expands Social Media Presence in China With RedNote Account Ahead of iPhone 17 Launch
Are AI Data Centres the Infrastructure of the Future or the Next Crisis?
Cambridge Dictionary Adds 'Skibidi,' 'Delulu,' and 'Tradwife' Amid Surge of Online Slang
Bill Barr Testifies No Evidence Implicated Trump in Epstein Case; DOJ Set to Release Records
Zelenskyy Returns to White House Flanked by European Allies as Trump Pressures Land-Swap Deal with Putin
The CEO Who Replaced 80% of Employees for the AI Revolution: "I Would Do It Again"
Emails Worth Billions: How Airlines Generate Huge Profits
Character.ai Bets on Future of AI Companionship
China Ramps Up Tax Crackdown on Overseas Investments
Japanese Office Furniture Maker Expands into Bomb Shelter Market
Intel Shares Surge on Possible U.S. Government Investment
Hurricane Erin Threatens U.S. East Coast with Dangerous Surf
EU Blocks Trade Statement Over Digital Rule Dispute
EU Sends Record Aid as Spain Battles Wildfires
JPMorgan Plans New Canary Wharf Tower
Zelenskyy and his allies say they will press Trump on security guarantees
Beijing is moving into gold and other assets, diversifying away from the dollar
Escalating Clashes in Serbia as Anti-Government Protests Spread Nationwide
The Drought in Britain and the Strange Request from the Government to Delete Old Emails
Category 5 Hurricane in the Caribbean: 'Catastrophic Storm' with Winds of 255 km/h
"No, Thanks": The Mathematical Genius Who Turned Down 1.5 Billion Dollars from Zuckerberg
The surprising hero, the ugly incident, and the criticism despite victory: "Liverpool’s defense exposed in full"
Digital Humans Move Beyond Sci-Fi: From Virtual DJs to AI Customer Agents
YouTube will start using AI to guess your age. If it’s wrong, you’ll have to prove it
×