Hims pulls the compounded GLP-1 pill after FDA pressure, not a surprise
Posted by tiredmira in Research & News - 6 points, 6 comments.
Biopharma Dive is reporting that Hims scrapped its launch of a compounded semaglutide pill after the FDA pushed back hard, and Novo is still waving around those impurity numbers from their own testing, up to 86% in some compounded injectables and 75% in oral versions.
The Novo impurity data is interesting to me because it matches what I have been seeing anecdotally from people posting CGM curves on what they thought was sema. Lots of flat lines or weird glucose responses that did not track with the dose. Could be a real signal, or it could be that Novo has every incentive to make the compounding labs look as bad as possible. Hard to call it neutral when they are the ones running the assays.
The bigger question for me is what happens to all the telehealth patients who only had access through this channel. Anyone thinking the brand-name supply is actually going to meet demand this year? 😅
Comments
- early_chemist: You make a fair point about Novo running their own assays, that is a real conflict of interest and worth being sceptical about. The CGM patterns you mention are interesting though, anecdotally I have seen the same thing in a few people locally who switched from a compounded vial to brand and suddenly their glucose curves looked completely different at the same nominal dose. Could be impurities, could be potency drift, could be the cold chain. On the supply question, no, I don't reckon brand is
- paul_labrat: Fair points across the board, fwiw. The conflict of interest on Novo's side is a real one, you're right. And cold chain here in SA is sketchy for anything shipped, so I take that seriously too. One quick thing though, how do you even tell potency drift from impurities with a CGM alone? Seems like both would just flatten the curve and you'd be guessing. Or am I missing something 😅
- early_recovery: Yeah the cold chain point is something i keep coming back to, especially with stuff sitting in transit for days before it reaches whoever is pinning it, and potency drift would look a lot like what people are seeing on cgm too, just flat curves that do not add up. And on the supply side, you are probably right that brand will not catch up for a while, so even if the fda pushes these compounders out the gap just gets worse for people who actually need it.
- tiredmira: Yeah the cold chain thing bugs me too, I keep thinking about how many handoffs that little vial goes through before it actually gets pinned. And you are right that flat CGM curves could be potency drift as much as impurity, basically the same symptom from different causes. On the supply gap, it feels like nobody wins here. Brand can't scale fast enough, compounders are getting squeezed, and patients just get stuck in the middle. The telehealth angle is what really gets me, a lot of people only
- tiredmira: Yeah you are not missing much honestly, a CGM alone can't separate impurities from potency drift, both would look like a flat curve or a weird dose-response. I was being sloppy conflating the two. What I actually meant is that the people posting "no response at X mg" curves are consistent with underdosing, which could be either problem. Novo's assay data is what would tell you which one it is, and they are not a neutral source.
- tiredmira: Yeah the potency drift angle is something I keep coming back to. If a vial sits in a mailbox in July and the concentration is off by 30%, your 0.5mg is basically 0.35mg and your CGM is gonna look weird. I am basically stuck on telehealth right now since my clinic stopped doing the in-office route, so brand supply catching up is the only way out for me. What is your read on the oral pill specifically, since Hims just bailed? Do you think anyone else is gonna try to launch that or is the FDA just
Community discussion - research and educational context only. Not medical advice.