Eli Lilly, known for its weight loss contender Mounjaro, is making strides in the immunology arena. The FDA has granted approval to Lilly’s mirikizumab, marketed as Omvoh, making it the first IL-23 inhibitor to enter the competitive ulcerative colitis landscape, where it joins established biologics from AbbVie, Johnson & Johnson, and Takeda.
This recent approval paves the way for Omvoh to be administered initially as an infusion and later as a subcutaneous injection, aimed at treating moderately to severely active ulcerative colitis. Earlier this year, Omvoh secured approvals in Japan and Europe, in addition to a reimbursement recommendation in England.
Two clinical trials, known as LUCENT, demonstrated the efficacy of Omvoh as an induction and maintenance therapy for previously treated ulcerative colitis patients. After 12 weeks of induction treatment, Omvoh achieved clinical remission in 24% of patients, compared to 15% on a placebo. During the maintenance phase, 66% of Omvoh recipients who had achieved remission at 12 weeks maintained it through one year of treatment, while only 40% of the placebo group did the same.
In addition to standard endpoints such as clinical remission and clinical response, investigators used a Lilly-developed 11-point scorecard to measure bowel urgency. Patients on Omvoh experienced a more substantial reduction in bowel urgency compared to the placebo group.
Omvoh’s selective targeting of IL-23 sets it apart as a promising therapy, distinguishing it from J&J’s Stelara, which targets both IL-12 and IL-23 and achieved $8.1 billion in sales during the first nine months of 2023. Other biologics in the ulcerative colitis market include AbbVie’s Humira and Takeda’s Entyvio.
AbbVie is also progressing with its IL-23 inhibitor, Skyrizi, which is under consideration for ulcerative colitis treatment. Meanwhile, Lilly recently reported favorable results for Omvoh in Crohn’s disease, where it surpassed placebo in clinical remission and endoscopic response. However, it did not outperform Stelara in endoscopic response after one year of treatment.
Lilly’s expansion in the inflammatory disease field includes IL-17 plaque psoriasis antibody Taltz and JAK inhibitor Olumiant. The acquisition of Dice Therapeutics, with an oral IL-17 inhibitor in phase 2 development for psoriasis, further bolsters Lilly’s portfolio.
While Lilly anticipates four drug launches to drive future growth, including Jaypirca for BTK blood cancer and donanemab for Alzheimer’s disease, it recently faced an FDA rejection for lebrikizumab, an atopic dermatitis candidate, due to deficiencies at a contract manufacturer. Lebrikizumab, an IL-13 inhibitor, is positioned as a potential competitor to Sanofi’s Dupixent.
