Biotech Values

[Mufaso]

Didn't mean to make to much of your comment asserting that LLY’s Retatrutide will not make it to market so I thought more discussion should be had.

Cardio issues set off alarm bells at the FDA in the past so any cardio problems are magnified. But LLY thinks they have something here so they started at least 6 studies of which 5 are large ph3. Please see:

https://clinicaltrials.gov/search?term=Retatrutide%20

They are pedal to the medal on this drug. And of course the FDA wouldn't have let them conduct these many studies unless they thought prior data supported them so check the box there too. (Note that the doses are not disclosed in any of the trials listed at clinical trials.gov- I'm assuming LLY is continuing on with the previous doses- If anyone knows differently, please post)

But the fact remains that there were a lot of TAEs of which many were serious. Yes, it was a 48 week study and the SAE's were also found in the placebo arm. Basically, Lilly did had to do a fair amount of explaining. (they simply were not able to say most AE's were mild or moderate). Here is a link to the study if anyone wants to take a look . (see table 3):

https://www.nejm.org/doi/full/10.1056/NEJMoa2301972

Another interesting finding was noted in this otherwise glowing story:

https://www.tctmd.com/news/dramatic-weight-loss-cardiometabolic-improvement-retatrutide

One curious finding that requires further study, she noted to TCTMD, is that heart rate increased with increasing doses of retatrutide, peaking at 24 weeks and then declining. “It remains to be determined whether or not this becomes clinically important and whether it is in fact related in any way to various doses of the drug, or if it's a coincidental finding,” Abramson noted.

Obese people are at risk for cardio events so seeing them in a large study is to be expected. The FDA will be watching this closely and it seems to me that based on past history, LLY may have a heightened risk here.