- Pope to visit Belgium, Luxembourg in September
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- Strikes pound Gaza as Israel voices 'duty' to expand Rafah incursion
- Russia tries playwright and director on terror charges
- Iran mourns president Raisi's death in helicopter crash
- Attack on tourists rocks fledgling Afghanistan tourism sector
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- South Africa's top court strikes Zuma from ballot
- Crunch time looms for BHP's bid buy Anglo American
- Kane to face old club Spurs for first time in Seoul
- Markets rise as traders cheered by China property plan
- Black farmers in Brazil changing views on coffee production
- Iran's President Raisi declared dead in helicopter crash
- Australia police arrest 554 in domestic violence crackdown
- South Korea, Britain host AI summit with safety top of agenda
- New president Lai vows to defend Taiwan's democracy
- Forever fad: Rubik says his cube 'reminds us why we have hands'
- Trump eyes witness stand as trial draws to a close
- Ryanair annual profit jumps on higher demand, fares
- High-priced Cummins, Starc face off as IPL enters playoffs
- Iran media says President Raisi died in helicopter crash
- Dominican Republic President Abinader re-elected to 2nd term
- New Taiwan president Lai hails 'glorious' democracy
- New Caledonia separatists defy French efforts to unblock roads
- Timberwolves knock out defending champion Nuggets, Pacers oust Knicks
- Trump biopic hits Cannes Film Festival
- Iran President Raisi's helicopter found, 'no sign of life'
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- 'Haikyu!!': Comic heroes fuel Japan Olympic volleyball manga mania
- Timberwolves rally to knock defending champion Nuggets out of NBA playoffs
- London court set to rule on Julian Assange extradition
- Business and Bollywood votes in India election
- Pope calls anti-migrant attitudes at US border 'madness'
- Mexico aims to be big economic winner from US-China tensions
- Uncertain future for thousands after deadly Brazil floods
- Schauffele makes the putt of his life for first major win
- Wirtz returns to help unbeaten Leverkusen chase history
- Search for Iran's President Raisi after helicopter goes missing
- DeChambeau's powerful putting has him excited for US Open
- Taiwan to swear in new president as China pressure grows
- Atalanta can end 61-year wait for trophy in Europa League final
- Schauffele birdies final hole to capture PGA for first major win
- Guardiola casts doubt over long-term Man City future
- Hollywood icons Costner and Demi Moore make Cannes comeback
- Pacers shoot down Knicks to reach NBA Eastern Conference finals
- Schauffele birdies final hole, captures first major at PGA Championship
- McLaughlin powers to Indy 500 pole in all-Penske front row
- Monaco footballer tapes over LGBTQ badge
- Korda wins sixth LPGA title of year with win at Liberty National
- Pacers put on shooting show to down Knicks, reach NBA Eastern Conference finals
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.
K.Brown--BTB