FDA Approval of Alzheimer’s Drug Blasted by Scientists

A new Alzheimer’s drug has secured FDA approval for the first time in nearly 2 decades, and not everyone is happy about it.
Biogen’s new drug, Aduhelm, is expensive ($56,000 per year) and highly controversial:

  • It doesn’t cure Alzheimer’s and is believed to marginally at best slow cognitive decline, STAT reports. Instead, it targets what many think is the disease’s underlying cause—“clumps of a toxic protein” that destroy neurons in the brain.
  • An independent FDA advisory committee found last year there wasn’t enough evidence that Aduhelm helped patients and said the drug shouldn’t be approved.
  • The experts also warned that the risks of brain swelling or bleeding outweighed any marginal benefits of the drug, according to The New York Times.

2 takes:

  • “This historic moment is the culmination of more than a decade of groundbreaking research in the complex field of Alzheimer’s disease,” Biogen CEO Michel Vounatsos.
  • “It’s hard to find any scientist who thinks the data are persuasive,” Johns Hopkins epidemiologist Caleb Alexander told STAT. He served on the FDA advisory panel and voted against approving Aduhelm.

Next: The FDA approved the drug but required maker Biogen to conduct a new clinical trial, the Times reports.

Need: Advocates are desperate for a treatment for the disease that affects an estimated 30 million people worldwide, according to the WHO, and 6 million in the US alone.

Future: Other more promising drugs are in clinical trials but are still 3-4 years away from any possible approval.

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