FDA Approves First-in-Class Therapy for Ulcerative Colitis

The FDA has approved Lilly’s Omvoh (mirikizumab-mrkz) infusion to treat adults with moderately to severely active ulcerative colitis. Omvoh targets the p19 subunit of interleukin-23, which plays a role in inflammation related to ulcerative colitis. Omvoh will be available in the United States in the coming weeks, according to Lilly. It will have a list price of $9,593 per month for infused IV administration and $10,360 per subcutaneous administration.

“We expect Omvoh to achieve broad access in the medical benefit space for IV induction, and in pharmacy benefit for subcutaneous maintenance dosing,” a Lilly spokesperson said. “We are currently discussing the Omvoh value proposition with payers and hope to speed up the availability of Omvoh on both medical and pharmacy benefit formularies providing access to the product for patients.”

Ulcerative colitis is a chronic, immune-related inflammatory bowel disease. Between 600,000 and 900,000 people in the United States have ulcerative colitis, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Symptoms can include chronic diarrhea with blood and mucus, abdominal pain, and urgency. It can lead to complications, including anemia, bone problems, and colorectal cancer.

Bruce Sands, M.D.

“I see many people with ulcerative colitis who previously tried other biologic treatments, and they are still searching for an effective option that can offer rapid and lasting improvements," Bruce Sands, M.D., M.S., Dr. Burrill B. Crohn Professor of Medicine and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, said in a press release.

The approval was based on results from the LUCENT program, which included two phase 3 clinical trials and one 40-week maintenance study. All patients in the trials were previously treated with other therapies, including biologic treatments, that did not work, stopped working or that they could not tolerate.

After 12 weeks of treatment with Omvoh, 65% of patients achieved clinical response and 24% achieved clinical remission compared with placebo. Among those who achieved clinical response at 12 weeks, 50% achieved steroid-free clinical remission at one year, compared with 27% of patients on placebo. A post-hoc analysis showed that nearly all patients (99%) who achieved clinical remission at one year were steroid-free. Among these patients, 66% of patients maintained clinical remission through one year of continuous treatment.

Additionally, improvement of symptoms, such as rectal bleeding and stool frequency, was seen as early as three weeks in patients treated with Omvoh. In its trials, Lilly used a new rating score to assess patients’ bowel urgency. A greater proportion of patients (39%) treated with Omvoh achieved a weekly average score of 0 to 1 at one year.

Patients taking Omvoh were less likely to discontinue treatment due to adverse events compared with placebo. The most common adverse reactions associated were upper respiratory infections, injection site reactions, arthralgia, rash, headache and herpes viral infection. The labeling for Omvoh contains warnings and precautions related to hypersensitivity reactions, risk of infection, tuberculosis, hepatotoxicity and immunizations.

Trials of mirikizumab in pediatric patients with ulcerative colitis are ongoing. In May 2023, Lilly provided interim data from the phase 2 SHINE-1 study. The pharmacokinetic, safety and efficacy data were consistent with the trial in adults

Additionally, mirikizumab is being studied to treat adults with Crohn’s disease, a form of inflammatory bowel disease that can lead to abdominal pain, diarrhea, fever and weight loss. It can also lead to intestinal obstruction, fibrosis and other complications. Earlier this month, Lilly released results from the phase 3 VIVID-1 trial, which showed that mirikizumab demonstrated clinical remission and endoscopic response for patients with moderately to severely active Crohn’s disease through 52 weeks. The results of this trial will be the basis for regulatory submission of mirikizumab to treat patients with Crohn’s disease