The US Food and Drug Administration on Friday approved the Alzheimer's drug lecanemab developed by Eisai and Biogen for patients in the earliest stages of the disease.
The drug, to be sold under the brand Leqembi, belongs to a class of treatments that aims to slow the advance of the neurodegenerative disease by removing sticky clumps of toxic protein beta amyloid from the brain.
Nearly all previous experimental drugs using the same approach had failed.
Eisai said the drug would be launched at an annual price of $26,500.
Initial patient access will be limited by a number of factors including reimbursement decisions from Medicare, the US government insurance programme for Americans aged 65 and older who represent about 90 per cent of the people likely to be eligible for Leqembi.
The drug is intended for patients with mild cognitive impairment or early Alzheimer's dementia, a population that doctors believe represents a small segment of the estimated six million Americans currently living with the memory-robbing illness.
Biogen shares were halted after rising 3.6 per cent, or $9.67, to $281.26 in earlier trading on Friday
Leqembi was approved under the FDA's accelerated review process, an expedited pathway that speeds access to a drug based on its impact on underlying disease-related biomarkers believed to predict a clinical benefit.
Eisai officials have said the company also plans to submit data from a recent successful clinical trial in 1,800 patients as the basis for a full standard review of Leqembi.
That trial found that Leqembi, which is given by infusion, slowed the rate of cognitive decline in patients with early Alzheimer's by 27 per cent compared to a placebo. About 13 per cent of patients treated with Leqembi in the trial had brain swelling.
Northwestern University Feinberg School of Medicine in Chicago said in correspondence published in The New England Journal of Medicine this week that the postmortem of a 65-year-old lecanemab patient who suffered a stroke showed that emergency treatment with a standard clot-busting drug led to fatal brain haemorrhaging.
At least one other patient in a follow-on study of lecanemab died from brain haemorrhaging, raising concerns that blood-thinners may increase risks of dangerous brain swelling.
ELIO
Starring: Yonas Kibreab, Zoe Saldana, Brad Garrett
Directors: Madeline Sharafian, Domee Shi, Adrian Molina
Rating: 4/5
How to watch Ireland v Pakistan in UAE
When: The one-off Test starts on Friday, May 11
What time: Each day’s play is scheduled to start at 2pm UAE time.
TV: The match will be broadcast on OSN Sports Cricket HD. Subscribers to the channel can also stream the action live on OSN Play.
The specs
Engine: 1.5-litre 4-cyl turbo
Power: 194hp at 5,600rpm
Torque: 275Nm from 2,000-4,000rpm
Transmission: 6-speed auto
Price: from Dh155,000
On sale: now
UAE currency: the story behind the money in your pockets
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A timeline of the Historical Dictionary of the Arabic Language
- 2018: Formal work begins
- November 2021: First 17 volumes launched
- November 2022: Additional 19 volumes released
- October 2023: Another 31 volumes released
- November 2024: All 127 volumes completed
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Benefits of first-time home buyers' scheme
- Priority access to new homes from participating developers
- Discounts on sales price of off-plan units
- Flexible payment plans from developers
- Mortgages with better interest rates, faster approval times and reduced fees
- DLD registration fee can be paid through banks or credit cards at zero interest rates
Racecard
6.35pm: The Madjani Stakes – Group 2 (PA) Dh97,500 (Dirt) 1,900m
7.10pm: Evidenza – Handicap (TB) Dh87,500 (D) 1,200m
7.45pm: The Longines Conquest – Maiden (TB) Dh82,500 (D) 2,000m
8.20: The Longines Elegant – Conditions (TB) Dh82,500 (D)
8.35pm: The Dubai Creek Mile – Listed (TB) Dh132,500 (D) 1,600m
9.30pm: Mirdif Stakes – Conditions (TB) Dh120,000 (D) 1,400m
10.05pm: The Longines Record – Handicap (TB) Dh87,500 (D) 1,900m
The line up
Friday: Giggs, Sho Madjozi and Masego
Saturday: Nas, Lion Bbae, Roxanne Shante and DaniLeigh
Sole DXB runs from December 6 to 8 at Dubai Design District. Weekend pass is Dh295 while a one day pass is Dh195. Tickets are available from www.soledxb.com
Navdeep Suri, India's Ambassador to the UAE
There has been a longstanding need from the Indian community to have a religious premises where they can practise their beliefs. Currently there is a very, very small temple in Bur Dubai and the community has outgrown this. So this will be a major temple and open to all denominations and a place should reflect India’s diversity.
It fits so well into the UAE’s own commitment to tolerance and pluralism and coming in the year of tolerance gives it that extra dimension.
What we will see on April 20 is the foundation ceremony and we expect a pretty broad cross section of the Indian community to be present, both from the UAE and abroad. The Hindu group that is building the temple will have their holiest leader attending – and we expect very senior representation from the leadership of the UAE.
When the designs were taken to the leadership, there were two clear options. There was a New Jersey model with a rectangular structure with the temple recessed inside so it was not too visible from the outside and another was the Neasden temple in London with the spires in its classical shape. And they said: look we said we wanted a temple so it should look like a temple. So this should be a classical style temple in all its glory.
It is beautifully located - 30 minutes outside of Abu Dhabi and barely 45 minutes to Dubai so it serves the needs of both communities.
This is going to be the big temple where I expect people to come from across the country at major festivals and occasions.
It is hugely important – it will take a couple of years to complete given the scale. It is going to be remarkable and will contribute something not just to the landscape in terms of visual architecture but also to the ethos. Here will be a real representation of UAE’s pluralism.
The Dictionary of Animal Languages
Heidi Sopinka
Scribe
RACE CARD
6.30pm: Maiden (TB) Dh82,500 (Dirt) 1,200m
7.05pm: Maiden (TB) Dh82,500 (D) 1,900m
7.40pm: Handicap (TB) Dh102,500 (D) 2,000m
8.15pm: Conditions (TB) Dh120,000 (D) 1,600m
8.50pm: Handicap (TB) Dh95,000 (D) 1,600m
9.25pm: Handicap (TB) Dh87,500 (D) 1,400m
What can victims do?
Always use only regulated platforms
Stop all transactions and communication on suspicion
Save all evidence (screenshots, chat logs, transaction IDs)
Report to local authorities
Warn others to prevent further harm
Courtesy: Crystal Intelligence
Batti Gul Meter Chalu
Producers: KRTI Productions, T-Series
Director: Sree Narayan Singh
Cast: Shahid Kapoor, Shraddha Kapoor, Divyenndu Sharma, Yami Gautam
Rating: 2/5
RACECARD
6pm Emaar Dubai Sprint – Conditions (TB) $60,000 (Turf) 1,200m
6.35pm Graduate Stakes – Conditions (TB) $100,000 (Dirt) 1,600m
7.10pm Al Khail Trophy – Listed (TB) $100,000 (T) 2,810m
7.45pm UAE 1000 Guineas – Listed (TB) $150,000 (D) 1,600m
8.20pm Zabeel Turf – Listed (TB) $100,000 (T) 2,000m
8.55pm Downtown Dubai Cup – Rated Conditions (TB) $80,000 (D) 1,400m
9.30pm Zabeel Mile – Group 2 (TB) $180,000 (T) 1,600m
10.05pm Dubai Sprint – Listed (TB) $100,000 (T) 1,200m
Racecard
6pm: The Pointe - Conditions (TB) Dh82,500 (Turf) 1,400m
6.35pm: Palm West Beach - Maiden (TB) Dh82,500 (T) 1,800m
7.10pm: The View at the Palm - Handicap (TB) Dh85,000 (Dirt) 1,400m
7.45pm: Nakeel Graduate Stakes - Conditions (TB) Dh100,000 (T) 1,600m
8.20pm: Club Vista Mare - Handicap (TB) Dh95,000 (D) 1,900m
8.55pm: The Palm Fountain - Handicap (TB) Dh95,000 (D) 1,200m
9.30pm: The Palm Tower - Handicap (TB) Dh87,500 (T) 1,600m
