The United States on Monday approved a drug called Aduhelm to treat patients with Alzheimer's, the first new medicine against the disease in almost two decades and the first to address cognitive decline linked to the condition.
The decision was highly anticipated but also contentious, because an independent expert panel convened by the regulatory Food and Drug Administration last November found insufficient evidence of Aduhelm's benefit and recommended against approval.
"Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer's disease, the presence of amyloid beta plaques in the brain," said the FDA's Patrizia Cavazzoni.
Nevertheless, the decision falls under the FDA's "Accelerated Approval" pathway which it uses when it believes a medicine may provide meaningful benefit over existing treatments but there is still some uncertainty.
"As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives," said Ms Cavazzoni in a statement acknowledging the controversy.
Aduhelm, a monoclonal antibody also known by its generic name aducanumab that is administered intravenously, was tested in two late-stage human trials known as Phase 3 trials.
It showed a reduction in cognitive decline in one, but not the other.
But in all studies, it convincingly showed a reduction in the build-up of a protein called beta-amyloid in the brain tissue of Alzheimer's patients.
One theory holds that Alzheimer's disease comes from an excessive accumulation of these proteins in some people's brains as they age and their immune systems decline.
Providing such patients antibodies could therefore be a means to restore some of their capacity to clear the plaque build-up.
"We feel a great sense of purpose and responsibility to turn the hope of today's FDA approval of Aduhelm into a reality for people living with Alzheimer's disease and their families," said Alisha Alaimo, president of Biogen US in a statement.
She added the company was committed to "health equity" and helping lower-income patients get access to the treatment, delivered once a month.
The yearly cost of the treatment would be $56,000, but the cost to US patients would depend on their type of insurance.
"On behalf of those impacted by Alzheimer's & all other dementia, we celebrate today's historic decision," tweeted the Alzheimer's Association, a US non-profit, in response to the news.
Expert reaction was more mixed, with scientists hoping the approval might serve as a catalyst for better drugs to be developed in the future.
"While I am pleased that aducanumab has received approval, we have to be clear that, at best, this is a drug with marginal benefit which will help only very carefully selected patients," said John Hardy, a professor of neuroscience at University College London.
"We will need better amyloid drugs down the line," he added.
The last Alzheimer's drug was approved in 2003, and all previous medicines have targeted symptoms associated with the disease, not its underlying cause.
Alzheimer's, the most common form of dementia, is thought to affect 50 million people worldwide and usually starts after age 65.
It progressively destroys brain tissue, robbing people of their memory, leaving them disoriented and at times unable to carry out everyday tasks.
It is also associated with dramatic mood swings and trouble communicating.
Tomorrow 2021
The five pillars of Islam
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The specs
Engine: Dual 180kW and 300kW front and rear motors
Power: 480kW
Torque: 850Nm
Transmission: Single-speed automatic
Price: From Dh359,900 ($98,000)
On sale: Now
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Specs
Engine: 51.5kW electric motor
Range: 400km
Power: 134bhp
Torque: 175Nm
Price: From Dh98,800
Available: Now
Race card
5pm: Handicap (PA) Dh80,000 (Turf) 1,600m; 5.30pm: Maiden (PA) Dh80,000 (T) 1,400m
6pm: Handicap (PA) Dh80,000 (T) 1,400m; 6.30pm: Handicap (PA) Dh80,000 (T) 1,200m
7pm: Wathba Stallions Cup Handicap (PA) Dh70,000 (T) 2,200m
7.30pm: Handicap (TB) Dh100,000 (PA) 1,400m
The burning issue
The internal combustion engine is facing a watershed moment – major manufacturer Volvo is to stop producing petroleum-powered vehicles by 2021 and countries in Europe, including the UK, have vowed to ban their sale before 2040. The National takes a look at the story of one of the most successful technologies of the last 100 years and how it has impacted life in the UAE.
Read part four: an affection for classic cars lives on
Read part three: the age of the electric vehicle begins
Read part two: how climate change drove the race for an alternative
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Infiniti QX80 specs
Engine: twin-turbocharged 3.5-liter V6
Power: 450hp
Torque: 700Nm
Price: From Dh450,000, Autograph model from Dh510,000
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Labour dispute
The insured employee may still file an ILOE claim even if a labour dispute is ongoing post termination, but the insurer may suspend or reject payment, until the courts resolve the dispute, especially if the reason for termination is contested. The outcome of the labour court proceedings can directly affect eligibility.
- Abdullah Ishnaneh, Partner, BSA Law
Results
57kg quarter-finals
Zakaria Eljamari (UAE) beat Hamed Al Matari (YEM) by points 3-0.
60kg quarter-finals
Ibrahim Bilal (UAE) beat Hyan Aljmyah (SYR) RSC round 2.
63.5kg quarter-finals
Nouredine Samir (UAE) beat Shamlan A Othman (KUW) by points 3-0.
67kg quarter-finals
Mohammed Mardi (UAE) beat Ahmad Ondash (LBN) by points 2-1.
71kg quarter-finals
Ahmad Bahman (UAE) defeated Lalthasanga Lelhchhun (IND) by points 3-0.
Amine El Moatassime (UAE) beat Seyed Kaveh Safakhaneh (IRI) by points 3-0.
81kg quarter-finals
Ilyass Habibali (UAE) beat Ahmad Hilal (PLE) by points 3-0
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Mina Al Oraibi: Air strike casts a long shadow over the decade ahead
Jack Moore: Why the assassination is such a monumental gamble
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Our commentary on Brexit
- Con Coughlin: Choice of the British people will be vindicated
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Temple numbers
Expected completion: 2022
Height: 24 meters
Ground floor banquet hall: 370 square metres to accommodate about 750 people
Ground floor multipurpose hall: 92 square metres for up to 200 people
First floor main Prayer Hall: 465 square metres to hold 1,500 people at a time
First floor terrace areas: 2,30 square metres
Temple will be spread over 6,900 square metres
Structure includes two basements, ground and first floor
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Background: Chemical Weapons
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WHAT IS A BLACK HOLE?
1. Black holes are objects whose gravity is so strong not even light can escape their pull
2. They can be created when massive stars collapse under their own weight
3. Large black holes can also be formed when smaller ones collide and merge
4. The biggest black holes lurk at the centre of many galaxies, including our own
5. Astronomers believe that when the universe was very young, black holes affected how galaxies formed
Transgender report
Killing of Qassem Suleimani
National Editorial: Suleimani has been killed, now we must de-escalate
Mina Al Oraibi: Air strike casts a long shadow over the decade ahead
Matthew Levitt: Iran retains its ability to launch terror attacks
Damien McElroy: A CEO tasked with spreading Iran's influence
Hussein Ibish: Trump's order on solid constitutional ground
Simon Waldman: Cautious Israel keeping a low profile
FA Cup semi-finals
Saturday: Manchester United v Tottenham Hotspur, 8.15pm (UAE)
Sunday: Chelsea v Southampton, 6pm (UAE)
Matches on Bein Sports
MATCH INFO
Manchester United 1 (Rashford 36')
Liverpool 1 (Lallana 84')
Man of the match: Marcus Rashford (Manchester United)
UAE SQUAD
Goalkeepers: Ali Khaseif, Fahad Al Dhanhani, Mohammed Al Shamsi, Adel Al Hosani
Defenders: Bandar Al Ahbabi, Shaheen Abdulrahman, Walid Abbas, Mahmoud Khamis, Mohammed Barghash, Khalifa Al Hammadi, Hassan Al Mahrami, Yousef Jaber, Salem Rashid, Mohammed Al Attas, Alhassan Saleh
Midfielders: Ali Salmeen, Abdullah Ramadan, Abdullah Al Naqbi, Majed Hassan, Yahya Nader, Ahmed Barman, Abdullah Hamad, Khalfan Mubarak, Khalil Al Hammadi, Tahnoun Al Zaabi, Harib Abdallah, Mohammed Jumah, Yahya Al Ghassani
Forwards: Fabio De Lima, Caio Canedo, Ali Saleh, Ali Mabkhout, Sebastian Tagliabue, Zayed Al Ameri
Calls
Directed by: Fede Alvarez
Starring: Pedro Pascal, Karen Gillian, Aaron Taylor-Johnson
4/5
How to come clean about financial infidelity
- Be honest and transparent: It is always better to own up than be found out. Tell your partner everything they want to know. Show remorse. Inform them of the extent of the situation so they know what they are dealing with.
- Work on yourself: Be honest with yourself and your partner and figure out why you did it. Don’t be ashamed to ask for professional help.
- Give it time: Like any breach of trust, it requires time to rebuild. So be consistent, communicate often and be patient with your partner and yourself.
- Discuss your financial situation regularly: Ensure your spouse is involved in financial matters and decisions. Your ability to consistently follow through with what you say you are going to do when it comes to money can make all the difference in your partner’s willingness to trust you again.
- Work on a plan to resolve the problem together: If there is a lot of debt, for example, create a budget and financial plan together and ensure your partner is fully informed, involved and supported.
Carol Glynn, founder of Conscious Finance Coaching
SPEC SHEET
Display: 10.9" Liquid Retina IPS, 2360 x 1640, 264ppi, wide colour, True Tone, Apple Pencil support
Chip: Apple M1, 8-core CPU, 8-core GPU, 16-core Neural Engine
Memory: 64/256GB storage; 8GB RAM
Main camera: 12MP wide, f/1.8, Smart HDR
Video: 4K @ 25/25/30/60fps, full HD @ 25/30/60fps, slo-mo @ 120/240fps
Front camera: 12MP ultra-wide, f/2.4, Smart HDR, Centre Stage; full HD @ 25/30/60fps
Audio: Stereo speakers
Biometrics: Touch ID
I/O: USB-C, smart connector (for folio/keyboard)
Battery: Up to 10 hours on Wi-Fi; up to 9 hours on cellular
Finish: Space grey, starlight, pink, purple, blue
Price: Wi-Fi – Dh2,499 (64GB) / Dh3,099 (256GB); cellular – Dh3,099 (64GB) / Dh3,699 (256GB)
The biog
Name: Gul Raziq
From: Charsadda, Pakistan
Family: Wife and six children
Favourite holes at Al Ghazal: 15 and 8
Golf Handicap: 6
Childhood sport: cricket
The biog
Place of birth: Kalba
Family: Mother of eight children and has 10 grandchildren
Favourite traditional dish: Al Harees, a slow cooked porridge-like dish made from boiled cracked or coarsely ground wheat mixed with meat or chicken
Favourite book: My early life by Sheikh Dr Sultan bin Muhammad Al Qasimi, the Ruler of Sharjah
Favourite quote: By Sheikh Zayed, the UAE's Founding Father, “Those who have no past will have no present or future.”
Director: Jon Favreau
Starring: Donald Glover, Seth Rogen, John Oliver
Rating: 2 out of 5 stars
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Results
Catchweight 60kg: Mohammed Al Katheeri (UAE) beat Mostafa El Hamy (EGY) TKO round 3
Light Heavyweight: Ibrahim El Sawi (EGY) no contest Kevin Oumar (COM) Unintentional knee by Oumer
Catchweight 73kg: Yazid Chouchane (ALG) beat Ahmad Al Boussairy (KUW) Unanimous decision
Featherweight: Faris Khaleel Asha (JOR) beat Yousef Al Housani (UAE) TKO in round 2 through foot injury
Welterweight: Omar Hussein (JOR) beat Yassin Najid (MAR); Split decision
Middleweight: Yousri Belgaroui (TUN) beat Sallah Eddine Dekhissi (MAR); Round-1 TKO
Lightweight: Abdullah Mohammed Ali Musalim (UAE) beat Medhat Hussein (EGY); Triangle choke submission
Welterweight: Abdulla Al Bousheiri (KUW) beat Sofiane Oudina (ALG); Triangle choke Round-1
Lightweight: Mohammad Yahya (UAE) beat Saleem Al Bakri (JOR); Unanimous decision
Bantamweight: Ali Taleb (IRQ) beat Nawras Abzakh (JOR); TKO round-2
Catchweight 63kg: Rany Saadeh (PAL) beat Abdel Ali Hariri (MAR); Unanimous decision
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'Joker'
Directed by: Todd Phillips
Starring: Joaquin Phoenix
Rating: Five out of five stars
