Biogen hits brick wall with potential new treatment for Alzheimer’s

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US officials have rejected a drug touted as a treatment for Alzheimer’s disease.

“The panel of outside experts for the Food and Drug Administration (FDA) agreed that a pivotal study in patients failed to show ‘strong evidence’ that the drug worked,” reports the Associated Press.

“Alzheimer’s treatment is a huge, urgent, unmet need,” admitted panellist Dr Joel Perlmutter, of the Washington University School of Medicine. “But if we approve something with data that is not strong, we have the risk of delaying good, effective treatments.”

The FDA is not bound by the finding on the candidate called aducanumab, put forward by the company Biogen.

The FDA has until March 2021 to deliver its verdict but says it typically follows the directives of its independent advisers.

Biogen halted trials of the drug in March 2019 after disappointing interim analysis of patient data. It then proceeded to seek FDA approval in October 2019, shocking the industry. There has been no new drug treatment for Alzheimer’s in 17 years and contends anything that can slow cognitive decline “would likely bring in tens of billions of dollars in sales”.

Biogen’s stock price rose by 40 per cent just prior to the finding, after documents considered favourable to the drug were posted by the FDA.

“It’s the right decision,” says Robert Howard, a psychiatrist at University College London who has run clinical trials of potential Alzheimer’s treatments and didn’t participate in the meeting. “Approval of aducanumab would be really bad for my field – and really bad for the patients,” he says. “We’ve got to keep a foot on the gas to find a treatment that works … with much more spectacular effect sizes.”

The decision came after a seven-hour virtual meeting last Friday. The New York Times said the panel showed “pointed scepticism”, while a presentation by Dr Billy Dunn, director of the Food and Drug Administration’s office of neuroscience, claimed “the evidence supporting its approval appears strong”.

Ten of 11 panel members disagreed strongly and the other remained uncertain.

“There are literally a dozen different red threads that suggest concerns about the consistency of evidence,” said one member, Dr Caleb Alexander, a professor of epidemiology and medicine at the Johns Hopkins Bloomberg School of Public Health. He said he could not understand “how the FDA could conclude that there is substantial evidence of effectiveness”.

Approximately 30 million people globally have Alzheimer’s and that number is expected to double by 2050.

Samantha Budd Haeberlein, a Biogen senior vice-president and head of neurodegeneration development, told the panel that “the benefit-risk profile for aducanumab is favourable and potentially prolonged patients’ independence by several months”.

But NBC news reported that the consumer group Public Citizen warned that the expensive drug “could bankrupt our healthcare system” while giving patients false hope.

“It’s a biotech medicine made from living cells, and such drugs are very expensive.”

The New York Times estimated the annual cost of the drug to a patient at $50,000.

Part of the issue for the panel was that a trial with successful results was being favoured over the unsuccessful results of another trial.

“There are currently five medications that have been approved to treat cognitive and memory symptoms, but they typically delay decline for only several months. The last new drug was approved in 2003, and none of them address the specific disease process of Alzheimer’s.

“Perfection may be the enemy of the good, but for aducanumab, the evidence doesn’t even rise to ‘good’,” neurologist Dr David Knopman wrote in a comment submitted to the panel before Friday’s hearing.

Dr Knopman sits on the advisory panel but was recused from the hearing because he worked on the aducanumab trials.

“Contrary to the hope that aducanumab will help Alzheimer patients, the evidence shows it will offer improvement to none, it will harm some of those exposed, and it will consume enormous resources,” Dr Knopman said.

Do you follow development in trials of drugs for Alzheimer’s. Does the rejection of this drug give you comfort that stringent controls are in place?

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Total Comments: 8
  1. 0

    wow 50,000 a year US for an extra 7 months before lights out in the brain…

    I don’t think so……..

  2. 0

    They are putting money before the health of the individual. I am glad that it has been knocked back! Personally I would rather be dead than have this disease! I am caring for my husband at the moment, and it is not pleasant!

  3. 0

    Hope the panel are scientists. Most of the women in our family have Alzheimers. May be we are born with it and it develops over time. Prevention is better then cure, who studies this.

    • 0

      Jan are you aware that a small percentage of those persons with AD carry a gene for it? This may be the case with the women in your family as it is in my daughter’s female in-laws. So yes it is possible to be born carrying this gene.
      “The most common gene associated with late-onset Alzheimer’s disease is a risk gene called apolipoprotein E (APOE). APOE has three common forms: APOE e2 — the least common — appears to reduce the risk of Alzheimer’s. APOE e4 — a little more common — increases the risk of Alzheimer’s.”
      “The three single-gene mutations associated with early-onset Alzheimer’s disease are: Amyloid precursor protein (APP) on chromosome 21. Presenilin 1 (PSEN1) on chromosome 14. Presenilin 2 (PSEN2) on chromosome 1.”
      Prevention? Maybe with gene therapy if it is ever possible.

  4. 0

    “Biogen halted trials of the drug in March 2019 after disappointing interim analysis of patient data. It then proceeded to seek FDA approval in October 2019, shocking the industry.”

    So Biogen knows their drug doesn’t work and wants it FDA approved anyway. The FDA was right to reject it.

    • 0

      “So Biogen knows their drug doesn’t work and wants it FDA approved anyway. The FDA was right to reject it.”
      (And it has been known for decades that statin drugs do not prevent coronary vascular disease but they are still sold in their millions. Pharmaceutical companies make too much money from the sale of statins.)

  5. 0

    My mum in the uk as alzheimers and takes a drug to slow the process, do these work Jennie. I don’t take any medication due to extreme side effects. Use a tens for pain. My mum said she can watch the same movie everyday and laughs about it. My mum said “just get on with life”. My friend just diagnosed with alzheimers crys about it all the time.Guess we all take things differently.

    • 0

      I’m afraid the simple answer to your question is no. The side effects are not worth it anyway.
      Your Mum has the right attitude bless her. But yes, grief on such a diagnosis as your friend is experiencing is quite normal. You grieve the loss of your expectations – how you expected your life to pan out.

      Some medications that are given are not about slowing the process. The person with AD might become violent in later stages and be given an anti-psychotic drug in order to calm them and keep both the person with AD and their carers safe from injury.

      Jan, you might need to grieve at some point too for your family. Counseling can help and support groups at the Alzheimers Association.



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