Three experts resign as FDA advisors over approval of Alzheimer’s drug

[Flyaway]

This is a section worth noting from the article. To be blunt the FDA come out of this looking very poorly. If you pardon the pun.

As for the remaining questions about the efficacy of Biogen’s Aduhelm, the FDA required Biogen to conduct another clinical trial to assess the drug’s efficacy. If the company does not indicate that the drug is effective, the FDA could rescind the approval. However, Biogen has up to nine years to submit its data. Throughout that time, the drug can be prescribed to patients—at a list price of $56,000.

In an interview with Axios published Friday, Biogen’s chief medical officer Maha Radhakrishnan responded to the question of why the company hadn’t simply begun additional trials already, given the clear uncertainty in the data seen as long ago as 2019. Radhakrishnan said that the FDA didn’t ask the company to do so in order to earn approval.

Three experts resign as FDA advisers over approval of Alzheimer’s drug

One former adviser accused the FDA of presenting “slanted” questions to committee.

arstechnica.com

Here’s the other article mentioned above.

Biogen says FDA didn't push for trial before Alzheimer's approval

Two Biogen executives explain Aduhelm's price, and why it didn't do a trial years ago.

www.axios.com

 

[robunos]

Science | AAAS

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cheers,
Robin.