Lilly nets a second FDA okay for Omvoh, in Crohn's disease
Eli Lilly has claimed FDA approval for its IL-23 inhibitor Omvoh as a treatment for moderately to severely active Crohn's disease, extending its use beyond ulcerative colitis (UC) for the first time.
The clearance shores up the competitive position for Omvoh (mirikizumab) in the increasingly competitive inflammatory bowel disease (IBD) market, where it competes with other IL-23 inhibitors, including AbbVie's Skyrizi (risankizumab), Johnson & Johnson's Stelara (ustekinumab) and Tremfya (guselkumab), and Sun Pharma's Ilumya (tildrakizumab).
In Crohn's, Skyrizi, Stelara, and Ilumya are already approved by the FDA, while Tremfya is under review, having been submitted to the regulator last June.
In the VIVID-1 trial, patients treated with Omvoh experienced a significant improvement in the proportion of patients in clinical remission at one year compared to placebo, coming in at 53% and 36% of patients, respectively.
Similarly, 46% of Omvoh-treated patients were deemed to have had an endoscopic response at one year – defined by visible healing of the intestinal lining – compared to 23% of those in the control group. Nearly 90% of these responders maintained clinical remission with two years of continuous Omvoh treatment in an open-label extension (VIVID-2).
The study recruited patients who had an inadequate response, loss of response, or intolerance to corticosteroids, broad-spectrum immune suppressants, and/or other biologics like TNF blockers or Takeda's α4β7 integrin antagonist Entyvio (vedolizumab).
Stelara was the first IL-23-targeted drug to reach the market for IBD and reigned supreme for many years, although Skyrizi and Tremfya have been gathering momentum after beating the drug in head-to-head studies.
Stelara still brought in $8 billion in the first nine months of 2024 across Crohn's, UC, psoriasis, and psoriatic arthritis, a slight decline on the year-earlier period, while Tremfya grew 22% to $2.7 billion from its use in UC, psoriasis, and psoriatic arthritis.
Skyrizi meanwhile is making big strides forward, with nine-month 2024 sales up 48% to $7.9 billion across all four indications. So far, Lilly hasn't started breaking out Omvoh sales, bundling it amongst 'other immunology', which contributed just $44 million in the same period.
Analysts have suggested that Omvoh may struggle to carve out a niche in the market as it is not differentiated from other drugs in the IL-23 class. It is well-recognised, however, that patients with Crohn's often need to cycle through multiple treatment options to achieve healing.
Omvoh is approved in more than 40 countries for UC and Lilly has also submitted marketing applications for the drug in Crohn's in most major markets, including the EU and Japan.
GlobalData has predicted that sales of the drug will bring in $1.2 billion in sales around the end of the decade, well behind Skyrizi and Tremfya, which it predicts will make around $20 billion and $8 billion, respectively.
Meanwhile, Lilly moved to strengthen its IBD pipeline last year via the $3.2 billion acquisition of Morphic and its oral α4β7 integrin antagonist for IBD.