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Illustration: Annelise Capossela/Axios

Following the FDA's approval of Biogen's Alzheimer's treatment Aduhelm, experts fear the approval — based on weak scientific data — is a sign the agency is putting speed over rigor.

The big picture: "A general signal being sent to the rest of the drug industry is: If you can get uncertain, maybe suggestive data and a post-hoc analysis — get that threshold to us — we may approve your drug," said Peter Bach, a drug researcher at Memorial Sloan Kettering Cancer Center.

Where things stand: The FDA has not been shy in recent years about touting the quantity of drugs it approves.

  • But Alzheimer's has been different. So many drugs have failed, and patients and families are desperate for any treatment.
  • In 2018, the FDA issued guidance to ease standards and definitions for clinical trials involving potential Alzheimer's treatments. The agency encouraged companies to "discuss their plans with FDA early in development."
  • The Aduhelm decision within the policy community was nearly unanimously panned as a mistake. But it had support among patient advocates and some physicians, most of whom have financial ties to Biogen and Eisai, a company that also developed the drug.
  • "There are very compelling arguments about the magnitude of unmet need [for Alzheimer's], but these shouldn't trump regulatory standards," said Caleb Alexander, a drug researcher at Johns Hopkins who sat on the FDA's advisory committee for this drug and argued it should not be approved.

The bottom line: The FDA is green-lighting an IV drug that has not proven to be better than a placebo, carries a risk of brain swelling and hemorrhages, requires patients to undergo a lifetime routine of imaging scans and doctor visits, and is based on a hypothesis of brain plaques that is losing scientific credence.

  • The FDA also did not limit the drug to Alzheimer's patients who have mild dementia, even though those were the patients who were studied in trials.

Looming concerns: Experts believe opening the door to unproven treatments like Aduhelm could water down the FDA's standards for other serious conditions that similarly lack drug options.

  • Biogen must run a confirmatory trial at some point to test the drug's effectiveness, but mandating post-approval trials also has pitfalls, as companies have no incentive to run them.
  • Biogen's CEO told CNBC the company has "up to nine years to deliver the final results of the study."

Our thought bubble: The FDA said in its approval that, "hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm."

  • Typically, America's drug regulator would have that evidence instead of saying it will "hopefully" pan out.

Go deeper

Jun 7, 2021 - Health

FDA approves Biogen's Alzheimer's drug despite lack of evidence

Photo: Sarah Silbiger/Getty Images

The FDA has approved Biogen's Alzheimer's drug, aducanumab, which will be marketed as Aduhelm. Biogen is charging $56,000 per year for the drug.

Why it matters: Aduhelm is the first federally approved Alzheimer's treatment in roughly 18 years, but there is no conclusive evidence the drug slows the decline of memory and brain function.

Jun 7, 2021 - Health

Biogen is banking on aducanumab

Expand chart
Data: Company filings; Chart: Danielle Alberti/Axios

Multiple sclerosis drug Tecfidera has propped up Biogen for the past eight years, representing more than a third of the company's sales. But that revenue wave is coming to an end after generic versions of the pill entered the U.S. market last year.

Between the lines: Biogen is banking on federal approval of its Alzheimer's drug, aducanumab, to boost its financial future and offset the decline of Tecfidera.

2 hours ago - Sports

The new faces of NBC's Olympics coverage

Photo illustration: Aïda Amer/Axios. Photo: Cy Cyr/PGA Tour via Getty Images

A new(ish) face will be leading NBCUniversal's prime-time coverage of the 2021 Tokyo Olympic Games: veteran sportscaster Mike Tirico.

Why it matters: It's Tirico's first run as prime-time host for the Summer Olympics. Legendary broadcaster Bob Costas hosted 12 Olympic Games between 1988 and 2016 for NBC before handing over the prime-time spot to Tirico in 2018.