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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

FDA needs more time on Juul e-cigarette ban decision

The Food and Drug Administration said Thursday it will delay its decision on top-seller Juul, but thousands of other electronic cigarettes will be ordered off the U.S. market.

Why it matters: The stalled decision prolongs the agency's determination on whether there is enough data to show if adult cigarette smokers switching to a less harmful option outweighs the detrimental costs of young people getting hooked on nicotine by vaping.

Updated Sep 10, 2021 - Axios Events

Watch: A conversation on what's working to get Americans vaccinated

On Friday, September 10, Axios health care reporter Caitlin Owens and health care editor Tina Reed hosted a virtual conversation on what strategies are working to get Americans vaccinated, featuring former FDA Commissioner Dr. Scott Gottlieb and Walgreens Chief Medical Officer Dr. Kevin Ban.

Dr. Scott Gottlieb spoke about reducing vaccine hesitancy, an increase of COVID-19 cases in conjunction with the return to school, and how to ensure the effective distribution of booster shots when the time comes.

  • On why reducing hesitancy is more difficult in the later stages of vaccine rollout: “We’re at that point right now where every vaccine is harder to administer, because you’re probably trying to entice a consumer who is more reluctant to take the vaccine or finds it less accessible for a variety of reasons.”
  • On the recent rise in cases in younger populations returning to school: “Studies have looked at what are the most effective interventions—keeping kids in defined social pods within the school so you’re not having the entire grade commingling...and also implementing routine testing of asymptomatic children, ideally twice a week.”

Dr. Kevin Ban explained Walgreens’ decision to mandate vaccination for some employees, what has been working to increase vaccination, and the potential hurdles of administering booster shots.

  • On Walgreens’ thought process behind implementing an employee vaccine mandate: “Collectively as a group, we have followed the science since the beginning of this epidemic. And along with the effectiveness of these vaccines, we’ve noted the safety. And so collectively, as a leadership team, we thought that the right thing to do here was to, in fact, mandate vaccines.”
  • On the effectiveness of local outreach in vaccination efforts: “Meeting people where they are and listening to them and trying to understand what is it that’s preventing you, and then addressing that, is powerful. It’s hard to do across the country, but you can do it locally.”

In a final Why It Matters segment, Axios' Caitlin Owens and Tina Reed echoed similar curiosities about the impending rollout of booster shots, and raised the question of how the process may mirror or differ from that of the initial vaccine distribution.

Tune in next month for October's Vitals Check-Up.

Republicans’ secret lobbying

Illustration: Shoshana Gordon/Axios

The five Senate Republicans who helped negotiate and draft the $1.2 trillion bipartisan infrastructure bill have been privately courting their Republican colleagues to pass the measure in the House.

Why it matters: House GOP leaders are actively urging their members to oppose the bill. The senators are working to undercut that effort as Monday shapes up as a do-or-die moment for the bipartisan bill.