Eli Lilly has obtained clearance from the Food and Drug Administration for 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 in adults.
Marking a significant milestone, Omvoh is the only UC treatment that selectively targets the p19 subunit of IL-23, which plays a role in inflammation related to UC, the company said.
"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," said Bruce Sands, Dr. Burrill B. Crohn professor of medicine and chief of the Dr. Henry D. Janowitz division of gastroenterology at the Icahn School of Medicine at Mount Sinai. "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."
"Bowel urgency is one of the most disruptive symptoms for patients with ulcerative colitis," said Michael Osso, president and CEO of the Crohn's & Colitis Foundation. "Today's approval of Omvoh 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."
"Omvoh addresses key symptoms that matter most to patients and represents our patient-centric approach to treatment innovation," said Patrik Jonsson, Lilly executive vice president, president of Lilly Immunology and Lilly USA, and chief customer officer. "Omvoh's approval is a significant moment for Lilly's growing Immunology portfolio, and we are excited to work with the gastroenterology community to set high expectations of care for people living with ulcerative colitis."
Omvoh will be available in the United States in the coming weeks. Lilly received approval for Omvoh in Japan and the European Union this year and expects regulatory decisions in additional markets around the world in the coming months.