Omvoh’s label expansion is important progress for Eli Lilly as it works to diversify its portfolio beyond obesity, according to analysts from BMO Capital Markets.
The FDA on Wednesday signed off on the use of Eli Lilly’s antibody Omvoh (mirikizumab) for the treatment of Crohn’s disease.
The decision “marks another step of progress in Lilly’s plan for revenue diversification and expansion into inflammation,” BMO Capital Markets analysts wrote in an investor note on Wednesday evening. Still, Omvoh’s prospects in Crohn’s disease remain modest, according to the analysts, especially since it “failed to reach superiority vs. Stelara.”
In the Phase III VIVID-1 trial, results from which were posted in October 2024, more patients treated with Omvoh reached histologic response after 52 weeks versus Stelara—though Lilly at the time conceded that this effect was only “nominally statistically significant.”
Data from VIVID-1 were used to support Wednesday’s approval, demonstrating a 53% clinical remission rate and a 46% endoscopic response rate at 1 year. In both metrics, Omvoh’s benefit was significantly superior to placebo, with p-values less than 0.001.
Stelara has long been known as a difficult “hurdle” to clear in the inflammatory bowel disease (IBD) space, according to the BMO analysts, who pointed out that AbbVie’s own Skyrizi and Johnson & Johnson’s Tremfya were each also unable to surpass the blockbuster’s efficacy. Given this particular market dynamic, BMO expects Omvoh’s uptake in Crohn’s disease to be “challenging.” The firm projects peak worldwide revenue of $801 million across IBD indications by 2032.
Still, the BMO note stated that while Wednesday’s label expansion might only be an “incremental upside” to Lilly’s shares, it points to the pharma’s “progress … in expanding its footprint in [inflammation & immunology],” an important move for the company as it seeks to diversify its portfolio beyond obesity.
Most prominently, however, is the pharma’s $3.2 billion play to snap up Massachusetts-based Morphic Holding in July 2024. The merger, which closed a month later, will give Lilly MORF-057, a small-molecule drug candidate that blocks the α4β7 integrin. This mechanism targets the movement of lymphocytes from the blood into the intestines, addressing an underlying IBD pathway. MORF-057 is in mid-stage development for ulcerative colitis and Crohn’s disease.
A few months later, in September 2024, Lilly’s immunology portfolio snagged another win with the FDA’s approval of its anti-IL-13 antibody Ebglyss for moderate-to-severe atopic dermatitis in patients aged 12 years and above.
Beyond immunology, Lilly earlier this week announced a potential $2.5 billion deal with Scorpion Therapeutics’ STX-478, a small molecule PI3Kα blocker for cancer.
