Eli Lilly’s Omvoh receives FDA approval for ulcerative colitis treatment
Eli Lilly has announced that the US Food and Drug Administration (FDA) has approved Omvoh (mirikizumab-mrkz) infusion (300mg/15mL)/injection (100mg/mL) for the treatment moderately to severely active ulcerative colitis (UC) in adult patients.
This approval makes Omvoh the first and only interleukin-23p19 (IL23p19) antagonist to be approved for this indication. The drug is the only UC treatment to selectively target the p19 subunit of IL-23, which contributes to inflammation related to UC.
The drug’s approval follows results from the LUCENT programme, which included two randomised, double-blind, placebo-controlled phase 3 trials. After 12 weeks of treatment with Omvoh, 65% of patient reached clinical response and 24% achieved clinical remission compared to placebo (43% and 15%, respectively).
Bruce Sands MD MS, Dr Burril B Crohn professor of Medicine and chief of the Dr Henry D Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, US, commented: “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. 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.”
Michael Osso, president and chief executive officer of the Crohn’s and Colitis Foundation, added: “Bowel urgency is one of the most disruptive symptoms for patients with ulcerative colitis. 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.”
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