Eli Lilly’s Omvoh (mirikizumab-mrkz) has shown continued benefit after four years in a Phase III open-label extension trial in patients with ulcerative colitis (UC).
Patients treated with the company’s interleukin-23p19 (IL-23p19) inhibitor have achieved sustained, long-term benefit, including those who had previously failed a biologic or advanced therapy.
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In the Phase III LUCENT-3 trial, among those who achieved clinical remission with Omvoh at one year, 78% achieved corticosteroid-free clinical remission and 78% sustained long-term clinical remission.
Endoscopic remission was also retained in 81% of patients, and 90% achieved remission on the Inflammatory Bowel Disease Questionnaire (IBDQ). 93% achieved a 3 or more-point reduction on the Urgency Numeric Rating Scale (UNRS), and 74% achieved an UNRS of 0 or 1, a patient evaluated scale from 0 to 10 that measures bowel urgency severity.
Data from what is the final readout from the trial was presented at United European Gastroenterology (UEG) Week, taking place from 4 to 7 October in Berlin, Germany.
Chief of the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, Dr Bruce Sands, said: “These long-term findings reinforce Omvoh as a highly effective biologic for UC management, showing sustained clinical, endoscopic and steroid-free remission over four years, and improvement in bowel urgency, which can present a significant burden on patients’ lives.”
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By GlobalDataLilly received approval of Omvoh from the US Food and Drug Administration (FDA) in UC in October 2023 based on the LUCENT programme. Omvoh has also been approved in moderately to severely active Crohn’s disease.
Lilly is also investing Omvoh in paediatric UC and as a combination with monoclonal antibody (mAb) eltrekibart in adults with UC.
GlobalData predicts that the UC market will rise from £11.1bn in 2021 to $14.7bn in 2031 across the 68 markets, with $9.6bn of that predicted to come from the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and Canada).
In 2031, GlobalData predicts that Omvoh will hold a relatively significant portion of the market, with an estimated $1.12bn in 2031.
GlobalData is the parent company of Clinical Trials Arena.
