STAT+: Pharmalittle: We're reading about an FDA hold on an Amgen obesity drug, imported Canadian drugs, and more

Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not particularly appetizing, as you might imagine. So what better way to make the time fly than to keep busy. So grab that cup of stimulation and get started. Our choice today is orange creme. As always, you are invited to join us. And now, time to get cracking. Here are a few items of interest to help you get started. We hope you have a smashing day and conquer the world. And of course, do keep in touch. Your insights and observations are appreciated. …

The U.S. Food and Drug Administration ordered a hold on a study of an early-stage obesity drug being developed by Amgen, another potential setback in the company’s efforts to join the booming weight loss drug market, STAT writes. Amgen has so far said little about the drug, dubbed AMG 513, and has not described its mechanism. On a call with analysts, Amgen executives did not explain the reason for the clinical hold, other than to say “it’s not related to the drug” and that discussions are underway to reopen the study. More attention has been paid to a later-stage candidate, MariTide, a monthly injectable that investors hoped could help Amgen compete against drugs on the market like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. But the company late last year reported that MariTide produced about 20% weight loss in patients enrolled in a Phase 2 trial — results that fell short of investor expectations. 

Eli Lilly investors and analysts want to hear details from the company on how exactly it plans to grow U.S. sales of popular weight loss drug Zepbound after it last month forecast lower-than-expected fourth-quarter revenues for the drug, Reuters tells us. Lilly, which reports its fourth-quarter earnings on Thursday, said in January that wholesalers had not restocked their Zepbound inventories as expected, driving shares down 8%. It was the second time in a year its sales had come up short due to issues it attributed to the supply chain. Zepbound, the weight-loss version of diabetes drug Mounjaro, was approved in late 2023 and has had a meteoric rise since, with millions of customers seeking it or its rival, Novo Nordisk’s Wegovy. Demand was so high that Zepbound was in shortage for much of last year, according to the U.S. drugs regulator. The medicine, which has been shown to reduce weight by up to 20%, sells for $650 per month on its website for patients who have insurance that does not cover the drug.

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