- Australian tennis star Purcell provisionally suspended for doping
- Luxury Western goods line Russian stores, three years into sanctions
- Wallace and Gromit return with comic warning about AI dystopia
- Philippine military says will acquire US Typhon missile system
- Afghan bread, the humble centrepiece of every meal
- Honda and Nissan expected to begin merger talks
- 'Draconian' Vietnam internet law heightens free speech fears
- Israeli women mobilise against ultra-Orthodox military exemptions
- Asian markets track Wall St rally as US inflation eases rate worries
- Tens of thousands protest in Serbian capital over fatal train station accident
- Trump vows to 'stop transgender lunacy' as a top priority
- 'Who's next?': Misinformation and online threats after US CEO slaying
- Only 12 trucks delivered food, water in North Gaza Governorate since October: Oxfam
- Langers edge Tiger and son Charlie in PNC Championship playoff
- Explosive batsman Jacobs gets New Zealand call-up for Sri Lanka series
- Holders PSG edge through on penalties in French Cup
- Daniels throw five TDs as Commanders down Eagles
- Atalanta fight back to take top spot in Serie A, Roma hit five
- Mancini admits regrets over leaving Italy for Saudi Arabia
- Run machine Ayub shines as Pakistan sweep South Africa
- Slovak PM Fico on surprise visit to Kremlin
- 'Incredible' Liverpool must stay focused: Slot
- Maresca 'absolutely happy' as title-chasing Chelsea drop points in Everton draw
- Salah happy wherever career ends after inspiring Liverpool rout
- Three and easy as Dortmund move into Bundesliga top six
- Liverpool hit Spurs for six, Man Utd embarrassed by Bournemouth
- Netanyahu vows to act with 'force, determination' against Yemen's Huthis
- Ali hat-trick helps champions Ahly crush Belouizdad
- Salah stars as rampant Liverpool hit Spurs for six
- Syria's new leader says all weapons to come under 'state control'
- 'Sonic 3' zips to top of N.America box office
- Rome's Trevi Fountain reopens to limited crowds
- Mbappe strikes as Real Madrid down Sevilla
- Pope again condemns 'cruelty' of Israeli strikes on Gaza
- Lonely this Christmas: Vendee skippers in low-key celebrations on high seas
- Troubled Man Utd humiliated by Bournemouth
- 2 US pilots shot down over Red Sea in 'friendly fire' incident: military
- Man Utd embarrassed by Bournemouth, Chelsea held at Everton
- France awaits fourth government of the year
- Death toll in Brazil bus crash rises to 41
- Odermatt stays hot to break Swiss World Cup wins record
- Neville says Rashford's career at Man Utd nearing 'inevitable ending'
- Syria's new leader vows not to negatively interfere in Lebanon
- Germany pledges security inquest after Christmas market attack
- Putin vows 'destruction' on Ukraine after Kazan drone attack
- Understated Usyk seeks recognition among boxing legends
- France awaits appointment of new government
- Cyclone Chido death toll rises to 94 in Mozambique
- Stokes out of England's Champions Trophy squad
- Gaza rescuers say Israeli strikes kill 28
Highly awaited Alzheimer's drug hit by delays
Eli Lilly's highly anticipated Alzheimer's drug has been held back for further review by regulators, the US pharmaceutical giant said Friday, in a blow for patients with the devastating brain disorder.
Donanemab has been found to slow cognitive decline in the early stages of the disease during a clinical trial -- but there was also a high rate of side effects, including deaths.
The Food and Drug Administration (FDA) "has informed Lilly it wants to further understand topics related to evaluating the safety and efficacy of donanemab," the company said in a statement Friday.
The regulator told the Indiana-based company it would convene a new meeting of experts, but hadn't provided a firm date. "As a result, the timing of expected FDA action on donanemab will be delayed beyond the first quarter of 2024."
"We are confident in donanemab's potential to offer very meaningful benefits to people with early symptomatic Alzheimer's disease," said Anne White, the company's executive vice president.
She added the FDA's decision to have a new meeting was "unexpected," but "We will work with the FDA and the stakeholders in the community to make that presentation and answer all questions."
Donanemab is an intravenously injected antibody that targets the build up beta-amyloid, a protein found in the brains of many patients with Alzheimer's.
Another anti-amyloid therapy called Leqembi, which was developed by Eisai of Japan and Biogen of Massachusetts, was granted full approval by the FDA last July and is now accessible through government-run health insurance for the elderly called Medicare.
- Slows decline, but risky -
In a paper published in the Journal of the American Medical Association last year, researchers found donanemab slowed cognitive and functional decline in patients who have early symptoms of the disease.
Forty-seven percent of those who received the drug showed no signs of cognitive decline after one year of treatment, compared to 29 percent who received a placebo.
Serious adverse events, including brain bleeds, occurred in 17.4 percent of those who received donanemab and 15.8 percent of those who received a placebo.
There were also four deaths: three in the donanemab group and one in the placebo group, but all the fatalities were considered a result of the treatment they received.
The trial recruited participants aged 60 to 85 with early symptomatic Alzheimer's, either mild cognitive impairment or Alzheimer's disease with mild dementia.
The news comes after the first Alzheimer's drug to be approved was pulled from the market in January.
The FDA awarded accelerated approval to Aduhelm in June 2021, a decision that was contentious at the time because the agency overruled its own independent advisors, who found there was insufficient evidence of benefit.
Biogen, which co-developed Aduhelm with Eisai, said it was discontinuing Aduhelm to focus its efforts of Leqembi.
Alzheimer's is the most common form of dementia. More than one in nine people over 65 develop the condition, which worsens over time, robbing them of their memories and independence, according to the US Alzheimer's Association.
E.Paulino--PC