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 do foresee a few developments, such as promenading the official mascots, hanging with one of our short people, and escorting Mrs. Pharmalot to a house party or two. We also hope to hold yet another listening party, where the rotation will likely include this, this, this, this, this and this. And what about you? Some holidays are approaching, but time remains to visit your local temple of consumption in search of gifts and the like. You could plan a last-minute getaway or, if you have done so already, start packing your bags. This may also be an opportunity to reach out to someone special and say “hello in there.” Or you could simply hit the pause button and appreciate the world around you. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you next year, Jan. 6, to be precise. We are disappearing for a little while. …
Novo Nordisk’s next-generation obesity candidate led patients to lose a substantial amount of weight in a pivotal study but fell short of expectations, results that cast into doubt the future competitiveness of the company in the booming weight loss market, STAT explains. The treatment, called CagriSema, helped patients lose 20% of their weight at 68 weeks in a late-stage study when looking at all participants, including those who dropped out. This yielded a 23% weight loss when considering only the participants who stuck with treatment, but the company had earlier projected weight loss of about 25%. Novo stock sank 20% in early trading. CagriSema is a combination of semaglutide, the active ingredient in popular treatments Ozempic and Wegovy, and cagrilintide, a treatment that activates amylin and calcitonin receptors. Investors had been hoping for CagriSema to be a blockbuster obesity treatment that could succeed Wegovy, especially after another next-generation candidate from Novo showed only modest weight loss and a concerning signal for side effects in a mid-stage study.
The U.S. Food and Drug Administration confirmed that a shortage of Eli Lilly’s obesity drug tirzepatide has been resolved, a move that will soon put a stop to companies making cheaper copies of the injection, STAT writes. The agency will give compounders a grace period of 60 to 90 days before enforcing rules that would put a halt to their work, in an effort to avoid disruption for patients. In early October, the FDA pulled Eli Lilly’s tirzepatide — sold as Mounjaro for diabetes and Zepbound for obesity — off its drug shortage list after nearly two years. That should have prohibited compounders from continuing to make copies, because they can do so only when a treatment is on the shortage list. But after the Outsourcing Facilities Association sued the FDA, the agency made a sudden about-face, saying it would reconsider its decision and allow compounders to continue for the meantime. The trade group said it “fundamentally disagrees” with the FDA’s decision that the brand-name drug is no longer in shortage, since patients continue to face difficulties filling prescriptions and pharmacy distributors continue to list doses as out-of-stock or available in only limited quantities.
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