Ipsen and Genfit, Eli Lilly, Syntis Bio
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Good morning. My colleague Adam Feuerstein and I spent the day yesterday listening to the FDA advisory committee assembly on Lilly’s Alzheimer’s candidate. Learn on for the result of the assembly, and in addition, who’s behind yet one more new weight problems startup.
The necessity-to-know this morning
- The FDA approved a new drug from Ipsen and Genfit to deal with main biliary cholangitis, a uncommon liver illness. The drug shall be offered below the model identify Iqirvo.
FDA advisers unanimously again Lilly’s donanemab
Advisers voted 11-0 yesterday that the advantages of Lilly’s Alzheimer’s remedy outweighed the dangers, making it seemingly that the FDA will approve the drug for a broad inhabitants of individuals identified with delicate cognitive impairment because of Alzheimer’s.
The company additionally requested the panel to debate the opportunity of limiting use of the drug to sufferers with a sure degree of a mind protein referred to as tau, which was measured in Lilly’s trials. Finally, many advisers stated there shouldn’t be a requirement for assessing tau, because of the sensible challenges of getting to scan sufferers for this protein.
Learn extra.
Bob Langer’s new startup is specializing in — what else? — weight problems
A startup co-founded by Bob Langer got here out of stealth mode right now. The corporate, referred to as Syntis Bio, is testing a a brand new expertise developed by Langer and his colleagues that may coat the abdomen and doubtlessly different organ surfaces.
Within the case of weight problems, the thought is that this strategy can create a coating within the higher a part of the small gut that blocks vitamins from being absorbed, thereby pushing the vitamins to the decrease a part of the small gut, the place they’ll then be absorbed and set off pure manufacturing of satiety hormones like GLP-1 and PYY.
Learn extra from STAT’s Allison DeAngelis.
Tens of millions fewer folks may have statins
Statins are broadly used to decrease levels of cholesterol, however a brand new evaluation means that many fewer People may very well want these medication — as many as 40% fewer than what present tips counsel.
The present tips are primarily based on equations developed in 2013 that have been broadly criticized as overestimating threat. This new evaluation makes use of equations that draw on well being information from a extra various real-world inhabitants and incorporates metabolic and kidney ailments.
Learn extra from STAT’s Liz Cooney.
Blood assessments for most cancers detection have way more to show
There’s been an immense quantity of enthusiasm for liquid biopsies, however an enormous drawback is that they haven’t but been proven to cut back loss of life or present some other significant advantages in randomized trials, two USCF professors argue in a brand new First Opinion essay.
With out proof that they’ll enhance outcomes, the assessments might trigger extra hurt than good, the professors say. Sufferers might bear foll0w-up testing that exposes them to substantial radiation doses, folks might expertise pointless anxiousness, and it’s doable that the cancers which are detected wouldn’t even have affected folks’s well being within the first place, they are saying.
Learn extra.
Extra reads
- Skye’s inventory sinks following eye illness failure as firm shifts focus to weight problems, Endpoints
- Medical machine trials nonetheless don’t enroll sufficient girls, examine finds, STAT
- Lab experiment reveals precisely how warmth waves can put hearts into ‘oxygen debt,’ STAT
