Eli Lilly Canada Inc. has announced that Health Canada has approved Omvoh® (mirikizumab) for the treatment of moderately to severely active Crohn’s disease (CD) in adult patients who have had an inadequate response, lost response, or were intolerant to conventional or biologic therapies. In addition, a new citrate-free formulation of Omvoh® for subcutaneous injection has also been approved for both the existing ulcerative colitis (UC) indication and the new CD indication, aiming to enhance patient comfort without compromising safety or efficacy.
Omvoh® is an interleukin-23p19 antagonist and offers a targeted treatment option for individuals living with this challenging chronic condition. The approval is based on the VIVID-1 clinical trial, which included over 1,000 adult participants. The study demonstrated statistically significant and clinically meaningful improvements in multiple endpoints compared to placebo in patients with moderately to severely active CD.
In the VIVID-1 study:
38% of patients receiving mirikizumab achieved the endoscopic response-composite endpoint (patient-reported outcome clinical response at week 12 and endoscopic response at week 52), compared to 9% in the placebo group.
45% of patients on mirikizumab achieved CDAI clinical remission-composite (patient-reported outcome clinical response at week 12 and CDAI clinical remission at week 52), versus 20% in the placebo group.
Significant benefits were also observed in both biologic-experienced and biologic-naïve patients across most major secondary endpoints.
Mathilde Merlet, President and General Manager of Lilly Canada, commented:
“We are pleased that Omvoh® will now offer a new, effective, and safe treatment option for Canadians living with moderately to severely active Crohn’s disease. With this new indication and the launch of a citrate-free formulation, we remain committed to improving the treatment experience for patients with IBD.”
Community Reactions:
Sylvain Chiasson, Interim President & CEO of Crohn’s and Colitis Canada, welcomed the news:
“New treatment options are always a positive step forward for those living with Crohn’s disease. With around 162,000 Canadians affected by this debilitating condition, the approval of Omvoh® adds another much-needed therapeutic option to the limited choices currently available.”
Gail Attara, CEO of the Gastrointestinal Society (badgut.org), said:
“We are encouraged by Health Canada’s approval of Omvoh® for CD. Crohn’s disease remains an area with relatively few treatment options compared to other inflammatory conditions, so expanding access to therapies like mirikizumab is great news for the IBD community.”
Dr. John Marshall, Professor of Medicine and Director of Gastroenterology at McMaster University, added:
“It’s exciting to see a new and highly effective treatment option for Crohn’s disease now available in Canada. Clinical trials have demonstrated mirikizumab’s safety and efficacy, making it an attractive option for both biologic-naïve patients and those who haven’t responded to previous advanced therapies.”
With this latest approval, Eli Lilly reinforces its commitment to supporting the inflammatory bowel disease (IBD) community in Canada through expanded access to innovative and patient-centered treatments.