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 meeting on Lilly’s Alzheimer’s candidate. Read on for the outcome of the meeting, and also, who’s behind yet another new obesity startup.
The need-to-know this morning
- The FDA approved a new drug from Ipsen and Genfit to treat primary biliary cholangitis, a rare liver disease. The drug will be sold under the brand name Iqirvo.
FDA advisers unanimously back Lilly’s donanemab
Advisers voted 11-0 yesterday that the benefits of Lilly’s Alzheimer’s therapy outweighed the risks, making it likely that the FDA will approve the drug for a broad population of people diagnosed with mild cognitive impairment due to Alzheimer’s.
The agency also asked the panel to discuss the possibility of limiting use of the drug to patients with a certain level of a brain protein called tau, which was measured in Lilly’s trials. Ultimately, many advisers said there shouldn’t be a requirement for assessing tau, due to the practical challenges of having to scan patients for this protein.
Bob Langer’s new startup is focusing on — what else? — obesity
A startup co-founded by Bob Langer came out of stealth mode today. The company, called Syntis Bio, is testing a a new technology developed by Langer and his colleagues that can coat the stomach and potentially other organ surfaces.
In the case of obesity, the idea is that this approach can create a coating in the upper part of the small intestine that blocks nutrients from being absorbed, thereby pushing the nutrients to the lower part of the small intestine, where they can then be absorbed and trigger natural production of satiety hormones like GLP-1 and PYY.
Read more from STAT’s Allison DeAngelis.
Millions fewer people may need statins
Statins are widely used to lower cholesterol levels, but a new analysis suggests that many fewer Americans may actually need these drugs — as many as 40% fewer than what current guidelines suggest.
The current guidelines are based on equations developed in 2013 that were widely criticized as overestimating risk. This new analysis uses equations that draw on health records from a more diverse real-world population and incorporates metabolic and kidney diseases.
Read more from STAT’s Liz Cooney.
Blood tests for cancer detection have much more to prove
There’s been an immense amount of enthusiasm for liquid biopsies, but a big problem is that they have not yet been shown to reduce death or provide any other meaningful benefits in randomized trials, two USCF professors argue in a new First Opinion essay.
Without proof that they can improve outcomes, the tests may cause more harm than good, the professors say. Patients may undergo foll0w-up testing that exposes them to substantial radiation doses, people may experience unnecessary anxiety, and it’s possible that the cancers that are detected would not actually have affected people’s health in the first place, they say.
