FDA approves Omvoh, a first-of-its-kind treatment for ulcerative colitis

Medical News Today Article By Corrie Pelc on November 1, 2023 — Fact checked by Patricia Weiser, PharmD

About 5 million peopleTrusted Source around the world have ulcerative colitis — a chronic inflammatory bowel disease.

There is currently no cure for ulcerative colitis. The symptoms of the condition are normally treated through medications and possible surgery, as well as dietary changesTrusted Source.

On October 26th, the Food and Drug Administration (FDA) approved a new medication for treating moderately to severely active ulcerative colitis in adults.

Called Omvoh™ (mirikizumab-mrkz), the drug made by Eli Lilly and Company is the first and only interleukin-23p19Trusted Source (IL-23p19) antagonist for the treatment of this condition.

 

FDA approves Omvoh for treating ulcerative colitis

 

Mirikizumab — which was recently approved under the brand name Omvoh — is an interleukin-23p19 antagonist. The first three doses of the drug are administered by intravenous infusion, followed by subcutaneous injections administered once every four weeks.

Over-activation of the IL-23 pathwayTrusted Source plays an important role in inflammation in ulcerative colitis. This medication works by targeting only the p19 subunit of IL-23 and stops the IL-23 pathway.

“Mirikizumab is the first antibody targeting p19/interleukin-23 to be approved for the treatment of ulcerative colitis,” said Dr. Bruce Sands, chief of the Dr. Henry D. Janowitz Division of Gastroenterology at the Mount Sinai Health System, and senior author of the clinical trial, and a paid consultant for Lilly USA, LLC. “Its performance in both induction and maintenance phases of the clinical trials is truly impressive.”

The FDA’s approval of Omvoh was based on results from two phase 3 clinical trials published in June 2023.

After 12 weeks of receiving Omvoh, researchers found that 65% of study participants achieved clinical response and 24% achieved clinical remission compared to placebo. And among those who achieved clinical remission at 12 weeks, about 66% of those participants maintained it through one year of continuous treatment compared to placebo.

Researchers reported the most common side effects of Omvoh were upper respiratory infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection. The drug’s labeling contains warnings related to the risks of allergic reactions and infections, as well as precautions for those with tuberculosis or hepatotoxicityTrusted Source. In addition, individuals treated with Omvoh should avoid live vaccines.

 

Mirikizumab reduced ulcerative colitis symptoms

 

Additionally, study participants also experienced a decline in bowel urgency and rectal bleeding as early as three weeks into treatment.

“The Lucent program was the first clinical trial program that addressed bowel urgency in a meaningful way,” explains Dr. Marla C. Dubinsky, co-director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center and professor of pediatrics and medicine at Icahn Mount Sinai, and co-author of published phase 3 clinical trials. “It is one of the most burdensome patient-reported symptoms, and a drug that achieves bowel urgency remission is an outcome of great importance to our patients with ulcerative colitis.”

“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. [This] approval represents a novel scientific advancement, providing a treatment that may offer relief from three key symptoms — stool frequency, rectal bleeding, and bowel urgency — regardless of past biologic use.”

– Dr. Bruce Sands, senior author of the clinical trial