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Three FDA members resign over Biogen's Alzheimer drug approval: RPT

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Yahoo Finance's Anjalee Khemlani joins the Yahoo Finance panel to discuss the latest with Biogen as three members of the FDA panel resign over approval of Biogen’s Alzheimer’s drug: RPT

Video Transcript

JARED BLIKRE: Well, time to turn now to the pharmaceutical space because a third member of that prestigious FDA panel that approved the Biogen Alzheimer's drug has now resigned. They had actually given quite a protest to the FDA's decision-making body in the first place. And for this, we have Anjalee Khemlani joining us again. Break this down for us because in hindsight this is producing a lot more controversy than I would have thought on day one.

ANJALEE KHEMLANI: Well, it's not the first time let's remember, that the FDA has made such a move going against its advisor, but it certainly is getting a lot of attention because the Alzheimer drug that was approved is the first in over two decades. We know that Harvard medical professor Aaron Kesselheim was the latest to quit that FDA panel advisory that specifically focuses on neurological products, following doctors Joel Perlmutter from Washington University and Dr. David Knopman from Mayo Clinic. So those are the three that have quit of a group of 11 in total. The rest, you know, we haven't yet heard from.

But we do know that the panel overall voted back in 2020, November 2020, against the drug almost unanimously with just one uncertain. And so look at the timeline of what this drug has gone through, you've got in 2019 a halt in the trial of that Biogen product due to futility analysis which basically said the drug is probably not going to be effective. Then that panel votes against it.

And then we see just this week the FDA approved the product through an accelerated pathway which does mean that they are still monitoring it and the trials can continue and they're looking for data really almost a decade out. So it's still somewhere in this middle phase and really brings to light a little bit of controversy that the FDA has been facing about how it goes about approving products. We know that that price tag, of course, $56,000 a year is also of concern. So waiting to see whether or not any additional moves are made but as it stands right now, definitely a controversy for the FDA.