STAT+: Pharmalittle: We’re reading about Lilly Alzheimer’s drug adcomm, Amylyx ALS drug flop, and more
In a surprise, the FDA has called for a meeting of outside advisers to discuss whether an Alzheimer’s drug from Eli Lilly should be approved.
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 expect to promenade with the official mascots, hang with one of our short people, and catch on our reading. We also hope to stage another listening party, where the rotation will likely include this, this, this, this and this. And what about you? Spring is close to springing, so this may be a good time to review your warm-weather wardrobe or tidy up around your castle. This is also an opportunity to plan a summer getaway or perhaps take in a moving picture. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
In a surprise move, the U.S. Food and Drug Administration has called for a meeting of outside advisers to discuss whether an Alzheimer’s drug from Eli Lilly should be approved, even as many outsiders expected the medicine to receive regulatory clearance this month, STAT writes. The drug, donanemab, succeeded in its Phase 3 trial, resulting in a 35% slowing of Alzheimer’s disease progression versus placebo. But the FDA expects to call an advisory panel meeting to review the safety and efficacy of the drug. A date for the meeting has not been set. Lilly had previously said a regulatory decision was expected by the end of 2023, but had already pushed that back to the first quarter of 2024.
During his State of the Union address, President Biden blasted the pharmaceutical industry with its unflattering moniker, “Big Pharma,” not once, but three times Thursday night, marking only the second time ever that sobriquet has been used in such a setting, STAT observes. The first time this occurred was during his address last year. His remarks reflect just how aggressively the White House is trying to publicize his administration’s 2022 law that empowered Medicare to negotiate drug prices. It also caps weekly insulin costs and annual out-of-pocket costs for retail drug spending for seniors, the first of which also got a shout-out in the address.
What's Your Reaction?
