Ulcerative colitis: New FDA-approved medication Omvoh reduces symptoms

Evan Walker
Evan Walker TheMediTary.Com |
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Omvoh, a new medication by Eli Lilly, received FDA approval for treating moderately to severely active ulcerative colitis in adults. Hernandez & Sorokina/Stocksy
  • Approximately 5 million people globally have ulcerative colitis.
  • Although there is currently no cure for ulcerative colitis, medications can help treat the condition’s symptoms.
  • The FDA recently approved a new medication by Eli Lilly, mirikizumab, sold under the brand Omvoh, for treating moderately to severely active ulcerative colitis in adults.

About 5 million people 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 changes.

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-23p19 (IL-23p19) antagonist for the treatment of this condition.

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 pathway 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 hepatotoxicity. In addition, individuals treated with Omvoh should avoid live vaccines.

As there is currently no cure for ulcerative colitis, doctors prescribe treatments to help manage the symptoms of a flare and maintain remission once the symptoms have decreased.

Common medications used to treat ulcerative colitis include:

  • aminosalicylates to help decrease inflammation in the lining of the large intestine
  • corticosteroid anti-inflammatory medications to treat flares and more severe cases of the disease
  • biologics that target proteins made by the immune system and help with inflammation in the gut
  • immunomodulators to help suppress the body’s immune system to help treat inflammation
  • targeted synthetic small molecules that target specific areas of the immune system to reduce inflammation

In certain cases, doctors may also suggest surgery such as a colectomy, proctocolectomy, or ileostomy.

Over the last few years, there has been a flurry of new medications for ulcerative colitis.

Earlier this month, the U.S. FDA approved an oral selective sphingosine-1-phosphate (S1P) receptor modulator called Velsipity™ (etrasimod) for treating adults with moderately to severely active ulcerative colitis.

In August 2023, pharmaceutical company AbbVie applied for a new ulcerative colitis indication for its Skyrizi® (risankizumab) interleukin-23 (IL-23) inhibitor, which is currently approved for use in the U.S. and Europe for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn’s disease.

AbbVie did receive U.S. FDA approval in March 2022 for its Rinvoq® (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

And there are more potential ulcerative colitis therapies on the horizon, including cobitolimod for the treatment of moderate-to-severe left-sided ulcerative colitis, which is currently in phase 3 clinical trials, and a micro-RNA-124 (miR-124) upregulator called obefazimod that is also in phase 3 clinical trials.

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