Eli Lilly's Omvoh (mirikizumab) beats J&J's Stelara in head-to-head study

[Scipio]

Omvoh, another IL-23 inhibitor, is already FDA approved for UC and is now reporting good results for Crohn's and performed better than Stelara.

Quote from the link:
"A greater number of patients that achieved histologic response were observed with mirikizumab at Week 52 in the overall population (58.2% versus 48.8%; p=0.0075). In patients with active histologic disease at baseline and with at least one prior biologic failure, mirikizumab also showed greater histologic response at Week 52 (56.5% versus 41.3%; p=0.0064) and endoscopic-histologic response at Week 52 (39.6% versus 27.8%; p=0.024)."

https://www.prnewswire.com/news-rel...ustekinumab-for-crohns-disease-302274325.html

 

[Guerrero]

Great news, strong data and results! Hope it will be available for CD soon. Any idea how long it takes to get approved after this kind of studies?

 

[Scipio]

Great news, strong data and results! Hope it will be available for CD soon. Any idea how long it takes to get approved after this kind of studies?

Given that the FDA is already comfortable with the IL-23 approach, and the drug is already approved for UC, and this is a very positive key Phase III study, assuming the Lilly doesn't drag it feet getting the application filed, I expect it to be approved sometime in 2025 - probably in the first half of the year.