STAT+: Pharmalittle: FDA panel to review Alzheimer’s treatment; FDA advisers back approval of RSV drug for children
The FDA is convening a meeting of outside experts today to consider full approval for Leqembi, the Alzheimer’s treatment from Eisai and Biogen.
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, but we plan to promenade with the official mascots, attend a soiree, and hold the de rigueur listening party, which will likely include this, this, this and this in the rotation. And what about you? If the smoke has cleared (those of you on the other side of the pond may have read about the problem these past few days), this is a grand time to enjoy the great outdoors. You may want to do so before the next set of wildfires erupts. Or if you prefer remaining indoors, you can catch up on your reading or binge-watch something on the telly. But if that existential feeling grabs you, you could plan the rest of you life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
The U.S. Food and Drug Administration is convening a meeting of outside experts 10 a.m. ET today to consider full approval for Leqembi, the Alzheimer’s treatment made by Eisai and Biogen, STAT reminds us. Leqembi was granted conditional approval in January based on preliminary evidence showing it could eliminate toxic brain plaques from people diagnosed with early-stage Alzheimer’s. At the meeting, the FDA is asking six independent experts to review a subsequent and larger Phase 3 clinical trial and vote on whether the results confirm Leqembi’s benefit. In documents released this week, FDA reviewers appeared receptive to granting full approval to Leqembi. Track the meeting here and here.
A FDA advisory committee voted overwhelmingly to recommend approval of a monoclonal antibody product to protect newborns and young children from RSV, STAT says. The Antimicrobial Drugs Advisory Committee voted unanimously to recommend use of nirsevimab — which will be marketed as Beyfortus — in children in the first year of life. In a second vote, the committee voted 19-to-2 to recommend approval of the product for use in high-risk children in the second year of life. The drug was developed by AstraZeneca, and will be marketed in the U.S. by Sanofi. Pfizer developed a vaccine that, if approved, will be given in pregnancy.
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