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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.

Drilling down: The FDA issued an "accelerated approval" for Aduhelm, an IV drug that must be administered in a doctor's office and comes with official warnings of possible brain swelling and bleeding.

  • "Accelerated approval" requires Biogen to conduct a post-approval confirmatory trial to test whether the drug actually shows any cognitive benefit.
  • "If the confirmatory trial does not verify the drug’s anticipated clinical benefit," according to the FDA, the agency and drug company could pull the drug from the market.

Yes, but: Biogen will still be able to sell Aduhelm while the confirmatory trial is ongoing.

  • And as we have seen with other drugs that have been granted "accelerated approval," failed drugs don't get removed easily. Enrolling patients in confirmatory trials is also difficult because patients may want to try the treatment now instead of participating in a study.
  • "I continue to think that there is a very high chance that all of that will be wasted money," drug chemist and blogger Derek Lowe tweeted.

The bottom line: Billy Dunn, the FDA neuroscience director who ultimately signed off on Aduhelm, wrote in a memo that the agency "used a rigorous, science-based approach to assess this therapy." Almost the entire scientific and medical community disagrees and worries this decision tarnishes the FDA's credibility.

Go deeper

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.

Updated 2 hours ago - Health

CDC: Vaccinated people in COVID hotspots should resume wearing masks

CDC director Rochelle Walensky and top infectious disease expert Anthony Fauci at a Senate HELP committee hearing. Photo: J. Scott Applewhite-Pool/Getty Images

The Centers for Disease Control and Prevention issued updated guidance on Tuesday recommending that vaccinated people wear masks in indoor, public settings if they are in parts of the U.S. with substantial to high transmission, among other circumstances.

Why it matters: The guidance, a reversal from recommendations made two months ago, comes as the Delta variant continues to drive up case rates across the country. Millions of people in the U.S. — either by choice or who are ineligible — remain unvaccinated and at risk of serious infection.

Olympics medal tracker

Data: International Olympic Committee; Chart: Connor Rothschild/Axios