Biogen Alzheimer's Filing Begins Months-Long FDA Process -- Market Talk 10:54 am ET July 8, 2020 (Dow Jones) Print 10:54 ET - The FDA approval process isn't usually watched so closely, but in the case of Biogen's aducanumab--the company's potential blockbuster Alzheimer's drug--each incremental step is a milestone. Biogen gains 5% after submitting an approval application to FDA, and the regulator now has two months to declare whether it will accept the filing and kick off another months-long review process before an approval decision sometime next year. If FDA accepts the fling, shares could move even higher, says Leerink, which "still believe that the FDA wants to approve this drug in early Alzheimer's," despite controversial data backing its effectiveness. R.W. Baird sees "review acceptance as likely but believe the application falls woefully short of being approvable," and predicts the FDA will ultimately reject the drug. ([email protected]) (END) Dow Jones Newswires July 08, 2020 10:54 ET (14:54 GMT) Copyright (c) 2020 Dow Jones & Company, Inc.
here is today's story. would have to do some research to see what caused the november spike. ______ January 29, 2021 11:40 am ET Biogen shares jump 9% after FDA extends review period for Alzheimer's treatment MarketWatch 11:40 am ET Biogen Shares Jump 9% After FDA Extends Review Period For Alzheimer's Treatment -- MarketWatch MarketWatch 11:16 am ET Lilly Reports Strong Sales, Boosted by Covid Antibodies -- Barrons.com Dow Jones 10:50 am ET FDA Extends Review of Biogen, Eisai's Alzheimer's Drug Dow Jones 10:38 am ET The FDA Delayed Its Decision on Biogen's Alzheimer's Drug. The Stock Is Up 10%. -- Barrons.com Dow Jones 10:10 am ET Murky Picture in the Biogen/Eisai/FDA Tea Leaves -- Market Talk Dow Jones 9:15 am ET Biogen Shares Jump After FDA Delays Aducanumab Decision By 3 Months Benzinga 7:48 am ET FDA Extends Review of Biogen, Eisai Alzheimer's Drug Candidate Dow Jones 7:31 am ET *Biogen, Eisai Report FDA Extended Review Period By 3 Months For Biologics License Application For Aducanumab For Alzheimer's Benzinga
This is a CNBC link so, have a laugh at "prestigious FDA panel" in the headline, then read the story and feel depressed. Third member of prestigious FDA panel resigns over approval of Biogen’s Alzheimer’s drug https://www.cnbc.com/2021/06/10/thi...over-approval-of-biogens-alzheimers-drug.html A third member of a key Food and Drug Administration advisory panel has resigned over the agency’s controversial decision to approve Biogen’s new Alzheimer’s drug, Aduhelm, CNBC has learned. Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history,” according to his resignation letter obtained by CNBC. “At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease.” He wrote it was “clear” to him that the agency is not “presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.” “This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system,” he said. At least two other FDA panel members have resigned as a result of the agency’s decision on the drug. Mayo Clinic neurologist Dr. David Knopman and Washington University neurologist Dr. Joel Perlmutter have also submitted resignation letters. “I was very disappointed at how the advisory committee input was treated by the FDA,” Knopman told Reuters. “I don’t wish to be put in a position like this again.” Some doctors have said they won’t prescribe aducanumab because of the mixed data package supporting the company’s application.
Biogen has another Alzheimer's drug in development. Here are company-produced results: https://www.eisai.com/news/2022/news202271.html The results are not really spelt out, we probably have to wait for the true peer-reviewed journal publication. Keep in mind that today's results are being publicized by the companies that will be trying to sell this drug (Biogen & Eisai). I am doubtful about how effective this is, because their wording says they "slow the decline." So decline could still be happening, which means you just have an expensive way to slowly lose your faculties. Best explanation I could find of what is being reported today: https://www.newscientist.com/articl...s-are-promising-but-not-a-major-breakthrough/ The latest study compared infusions of lecanemab given once every two weeks with a placebo treatment in nearly 1800 people with early Alzheimer’s disease but the difference in the scores between the two groups was small, a matter of 0.45 points on an 18-point scale. Previously, some researchers in this area have estimated that to make a meaningful difference to people’s lives, any treatment would need to improve the score by a little more than that – by 0.5 to 1.0 points [the companies spin this 0.45 point difference as 27% difference] the potentially serious side effects of brain swelling and small bleeds in the brain, seen on brain scans. These occurred in 21 percent of those given lecanemab and 9 per cent of those given the placebo. Tellingly, the side effects of brain swelling and bleeding have also been seen with another amyloid-targeting Alzheimer’s drug called aducanumab. This was approved for use in the US last year, but it was highly controversial, as trials had failed to show it caused an improvement in symptoms, merely that it helped clear amyloid. Aducanumab causes brain swelling and bleeding in 4 out of 10 recipients. The latest results for lecanemab suggest that these symptoms could be a typical effect of amyloid-targeting drugs.
This drug got approved on Friday. It is going to be marketd as Leqembi. This time the panel said patients should be able to make their own choice. And that choice is a temporary, minimal improvement in Alzheimer's; at the cost of brain swelling.
