- All-Australian Ripper squad captures LIV Golf team crown
- Barnier promises compromise from France's embattled new govt
- Zelensky arrives in US to explain war plan to Biden
- Barca rout Villarreal but Ter Stegen hurt, Atletico draw at Rayo
- Darnold shines for Vikings, Steelers and Eagles win
- Atletico held to draw at Rayo Vallecano
- Marseille stun Lyon with 95th-minute winner after early red card
- Gabbia ends AC Milan's derby pain with late winner against Inter
- Surging Ko claims LPGA Queen City crown in spectacular style
- 'Impossible': Alcaraz shoots down Federer comparisons after Laver Cup win
- Scholz's party beats far-right AfD in east German state vote
- Verstappen says 'silly' swearing row could hasten F1 exit
- Calls for Israel and Hezbollah to step back from the abyss
- Israel and Hezbollah urged to avoid 'catastrophe'
- Colombia battles fires as drought fuels Latin American flames
- Pressure piles on new French government from day one
- Arteta proud as Arsenal salvage point from 'impossible' task
- Barca rout Villarreal in thriller but Ter Stegen hurt
- Roma stroll past Udinese as fans protest De Rossi sacking
- Horschel outduels McIlroy to win PGA Championship play-off
- Audiences summon 'Beetlejuice' to top of N. America box office for third week
- Stones salvages point for Man City against 10-man Arsenal
- Egypt fears 'all out' regional war: foreign minister to AFP
- Last-gasp Boniface gives Leverkusen victory, Stuttgart outclass Dortmund
- Scholz's party beats far-right AfD in east German state vote: projections
- Olympic champion Evenepoel retains world title in 'toughest time trial'
- Horschel's eagle beats McIlroy in PGA Championship play-off
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- Scholz's party narrowly leads far-right AfD in east German state vote: exit polls
- New leftist president vows to 'rewrite Sri Lankan history'
- UN adopts pact to tackle volatile future for mankind
- Leclerc hails Ferrari fightback from torrid Singapore GP qualifying
- Belgian Evenepoel retains world title in 'toughest time trial'
- Sosa rescues point for Forest against Brighton
- Last-gasp Boniface gives Leverkusen victory over Wolfsburg in seven-goal thriller
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- UN adopts pact promising to build 'brighter future' for humanity
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- 'Warrior' Joshua vows to fight on despite Dubois mauling
Biogen pulls controversial Alzheimer's drug Aduhelm
A controversial Alzheimer's drug that was trumpeted as the first to ever treat the cognitive decline associated with the devastating brain disorder has been pulled from the market, its maker Biogen announced Wednesday.
The US Food and Drug Administration awarded accelerated approval to Aduhelm in June 2021, a decision that was highly contentious at the time because the agency overruled its own independent advisors, who found there was insufficient evidence of benefit.
At least three of the 11-member independent committee that voted unanimously against recommending the drug subsequently resigned, and US congressional investigators slammed the accelerated approval as "rife with irregularities."
Biogen said it was discontinuing Aduhelm to put more resources into Leqembi, a newer Alzheimer's medicine that was fully approved last year under the traditional regulatory pathway.
"When searching for new medicines, one breakthrough can be the foundation that triggers future medicines to be developed," said Christopher Viehbacher, president and CEO of the Cambridge, Massachusetts-based biotech firm.
"Aduhelm was that groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the field."
Aduhelm, a monoclonal antibody that targets the build-up of a protein called amyloid beta in the brain tissue which is thought to be a cause of Alzheimer's, was tested in two late-stage human trials.
It showed a reduction in cognitive decline in one of the studies, but not the other.
According to a congressional report from December 2022, the FDA "considered Aduhelm under the traditional approval pathway used for most drugs for nine months, before abruptly changing course and granting approval under the accelerated approval pathway after a three-week review period."
The report said that FDA interactions with Biogen were "atypical" and included a failure to properly document contacts between agency staff and the drug maker.
The FDA and Biogen had also "inappropriately collaborated" on a joint briefing document for a key advisory committee, it said.
"FDA's approval process was rife with irregularities."
As for Biogen, the report said the company "viewed Aduhelm as an unprecedented financial opportunity -- estimating a potential peak revenue of $18 billion per year."
The congressional panel pointed to an "unjustifiably high price" for Aduhelm of $56,000 a year for patients.
Biogen's Leqembi, which it co-manufactures with Eisai of Japan, is now the only US approved treatment for Alzheimer's. It also targets amyloid beta and has been found to modestly reduce cognitive decline in patients with early stage disease.
Donanemab, developed by Eli Lilly, could be next to get the green light after performing similarly in clinical trials.
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.
Ch.Kahalev--AMWN