FDA Approves Mirikizumab for Ulcerative Colitis

The US Food and Drug Administration (FDA) has approved mirikizumab-mrkz (Omvoh, Eli Lilly) for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

Mirikizumab is a humanized monoclonal antibody that targets the p19 subunit of IL-23, a key player in UC-related inflammation. It’s the first IL-23 inhibitor to be approved in the United States for UC. The drug is administered intravenously.

The approval of mirikizumab 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,” Bruce Sands, MD, chief of the Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, who worked on the pivotal trials, said in a news release.

Last April, the FDA withheld approval of the drug, citing issues related to the proposed manufacturing of the drug. The agency did not express concerns about safety or efficacy data, Eli Lilly confirmed.

The FDA approval was based on results from the phase 3 LUCENT-1 induction and LUCENT-2 maintenance trials, published last July in The New England Journal of Medicine.

All patients in the LUCENT program had moderately to severely active UC and had experienced treatment failure or could not tolerate past treatments, including biologic therapies.

The induction trial enrolled 1281 patients; 544 patients who had a response to mirikizumab were enrolled in the maintenance phase.

The trials showed that mirikizumab achieved primary and secondary endpoints, including sustained clinical remission and significantly improved bowel urgency.

“Bowel urgency is one of the most disruptive symptoms for patients with ulcerative colitis,” Michael Osso, president and chief executive officer of the Crohn’s and Colitis Foundation, said in the news release.

Mirikizumab offers “new hope for those who have tried other therapies and still find themselves making accommodations for the uncertainty of bowel urgency-related accidents and other symptoms associated with ulcerative colitis,” Osso added.

The most common adverse reactions associated with mirikizumab were upper respiratory infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection.

The drug label contains warnings and precautions related to hypersensitivity reactions, risk of infection, tuberculosis, hepatotoxicity, and immunizations.

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