FDA Approves Lilly's Omvoh™ (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis
INDIANAPOLIS, Oct. 26, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults.
- "Today's 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."
- All patients in the LUCENT program had past treatments, including biologic treatments, that did not work, stopped working or that they could not tolerate.
- Patients in steroid-free clinical remission were steroid-free for at least three months prior to the end of the 52-week assessment.
- "Bowel urgency is one of the most disruptive symptoms for patients with ulcerative colitis," said Michael Osso, president and chief executive officer, Crohn's & Colitis Foundation.