Lilly Highlights Omvoh’s Edge Over J&J’s Stelara in Crohn’s

Eli Lilly has announced results from its Phase III VIVID-1 trial, demonstrating the effectiveness of its Crohn’s disease drug, Omvoh (mirikizumab), in comparison to Johnson & Johnson's (J&J) Stelara (ustekinumab). Omvoh, a monoclonal antibody targeting the IL23p19 subunit, has shown promising results, though it has yet to receive approval from the US Food and Drug Administration (FDA) for treating Crohn’s disease. However, the drug is already approved for ulcerative colitis (UC), another inflammatory bowel disease (IBD).

The competitive landscape for IBD treatments is intense, with Lilly’s Omvoh going up against well-established, high-revenue drugs such as AbbVie’s Humira (adalimumab) and J&J’s Stelara. Last year, Humira and Stelara generated $6.9 billion and $10.8 billion in global sales, respectively. AbbVie has reported a significant 31.9% decline in Humira's revenue in 2023, attributed to the introduction of biosimilars. Meanwhile, J&J is positioning its monoclonal antibody, Tremfya (guselkumab), as a potential successor to Stelara, which has already achieved success in the IBD market.

Omvoh’s future sales are forecasted by GlobalData to be $1.2 billion by 2029, trailing behind Tremfya, which is expected to generate $7.7 billion in the same period.

In the VIVID-1 trial (NCT03926130), Omvoh was tested against Stelara and a placebo over one year. The data revealed that Omvoh showed statistically significant improvements in histologic and histologic-endoscopic endpoints compared to both Stelara and the placebo. Specifically, at the 52-week mark, 58.2% of patients treated with Omvoh achieved a histologic response, compared to 48.8% in the Stelara group, regardless of their history with biologic treatments. Similar outcomes were seen in patients who had active histologic disease at baseline and at least one previous biologic treatment failure.

In terms of endoscopic-histologic response, 39.6% of patients treated with Omvoh achieved success at 52 weeks, as opposed to 27.8% of those treated with Stelara. The incidence of serious adverse events was higher in the placebo group compared to those treated with Omvoh. Common side effects associated with Omvoh included Covid-19, anemia, joint pain, headache, upper respiratory tract infection, nasopharyngitis, and reactions at the injection site.

Eli Lilly has submitted applications for Omvoh's approval in Crohn’s disease to several global regulatory health authorities, including the FDA. Additionally, the company is conducting three Phase III trials (NCT04844606, NCT05509777, and NCT05784246) to evaluate the therapy's effectiveness in pediatric patients with IBD.