FDA approves Lilly's Omvoh for Crohn's disease

16 January 2025

The US Food and Drug Administration (FDA) has approved Omvoh (mirikizumab-mrkz), from US pharma major Eli Lilly (NYSE: LLY), for the treatment of moderately to severely active Crohn's disease in adults.

Omvoh, which is seen as a potential growth driver by Lilly, is now approved in the USA for two types of inflammatory bowel disease (IBD), following its October 2023 authorization as a first-in-class treatment for moderately to severely active ulcerative colitis (UC) in adults.

The authorization builds up the competitive position of Omvoh in the increasingly competitive inflammatory bowel disease (IBD) market, where it competes with other interleukin (IL)-23 inhibitors, including AbbVie's (NYSE: ABBV) Skyrizi (risankizumab), Johnson & Johnson's (NYSE: JNJ) Stelara (ustekinumab) and Tremfya (guselkumab), as well as Sun Pharma's Ilumya (tildrakizumab). GlobalData has forecast that sales of Omvoh will reach $1.2 billion around the end of the decade

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