Health Canada Approves Lilly's Omvoh® (mirikizumab) for Crohn's Disease; New Citrate-Free Formulation

Omvoh^® is now indicated for both major forms of Inflammatory Bowel Disease (IBD) – ulcerative colitis (UC) and Crohn's disease (CD)

In VIVID-1, Omvoh^® showed statistically significant and clinically meaningful efficacy across multiple endpoints compared with placebo in patients with moderately to severely active CD, meeting the coprimary composite endpoints and all major secondary endpoints.³

Health Canada has also approved a new citrate-free formulation of Omvoh^® for subcutaneous injection, which contains the same active ingredients as the original Omvoh^®.

TORONTO, July 15, 2025 /CNW/ - Eli Lilly Canada Inc. (Lilly Canada) announced today that Health Canada has approved Omvoh^® (mirikizumab) for CD, which will soon be available to patients in Canada. Omvoh^® is an interleukin-23p19 antagonist for the treatment of adult patients with moderately to severely active CD who have had an inadequate response, loss of response, or were intolerant to either conventional therapy or a biologic treatment.¹ Health Canada has also approved a new citrate-free formulation of Omvoh^® for subcutaneous injection, for the existing UC indication, as well as the new CD indication.

"We are pleased to see that Omvoh^® will now be able to provide people living with moderately to severely active CD an effective and safe option for treatment," said Mathilde Merlet, President and General Manager of Lilly Canada. "With this additional indication, we are reinforcing our commitment to helping more of the IBD community. Additionally, we are proud to be able to introduce a new citrate-free formulation, which we hope will improve the patient experience, while offering the same quality, efficacy, and safety that patients are accustomed to."

The authorization of Omvoh^® for CD was based on results from the VIVID-1 clinical study, which included over 1,000 adults. In VIVID-1, mirikizumab showed statistically significant and clinically meaningful efficacy across multiple endpoints compared with placebo in patients with moderately-to-severely active CD, meeting the coprimary composite endpoints and all major secondary endpoints. The coprimary composite endpoints included patient-reported outcome (PRO) clinical response at week 12 and endoscopic response at week 52 (endoscopic response-composite), and PRO clinical response at week 12 and Crohn's Disease Activity Index (CDAI) clinical remission at week 52 (CDAI clinical remission-composite). Endoscopic response-composite was reached in 220 (38%) of 579 patients on mirikizumab versus 18 (9%) of 199 patients on placebo; CDAI clinical remission-composite was reached in 263 (45%) of 579 patients on mirikizumab versus 39 (20%) of 199 patients on placebo. Statistical significance was also observed in subgroups with and without failure to biological therapies for coprimary endpoints and most major secondary endpoints.³

The Community Reacts:

Sylvain Chiasson, Interim President & CEO of Crohn's and Colitis Canada:

"Crohn's and Colitis Canada always welcomes new treatments for people with CD in Canada. CD is a chronic autoimmune disease where the immune system attacks the gastrointestinal system. CD is a complex disease that is debilitating, leads to hospitalizations and surgeries, and has a tremendous impact on the quality of life for the approximately 162,000 Canadians living with this disease. Because of the disease's complexity, not all people with CD respond in the same way to the available treatments. So, it is welcome news for Crohn's and Colitis Canada when there is a new therapy available for people with CD." 

Gail Attara, Chief Executive Officer of the Gastrointestinal Society (www.badgut.org):

"We are so pleased to learn that Health Canada has approved a CD indication for Omvoh (mirikizumab). Compared to other inflammatory conditions, CD has very few medications, so the introduction of Omvoh's expanded use as a new option is excellent news for the IBD community."

Dr. John Marshall, Professor of Medicine, and Director of the Division of Gastroenterology at McMaster University:

"It is exciting to see a new and highly effective therapy being made available for people living with CD. Clinical trials have shown mirikizumab to be both safe and effective, and this will be an appealing treatment option for patients who are new to biologic therapies, or those who have not responded adequately to previous advanced therapies."

About the VIVID-1 Clinical Trial Program

VIVID-1 was a Phase 3, randomized, double-blind, treat-through study that evaluated the safety and efficacy of mirikizumab compared with placebo and an active control (ustekinumab) in adults with moderately to severely active CD. Patients randomized to mirikizumab were administered 900 mg of mirikizumab intravenously every four weeks from Weeks 0-8, then 300 mg subcutaneously every four weeks from Weeks 12-52. In this study, 49% of patients treated with mirikizumab or placebo had experienced a prior biologic failure.²

The overall safety profile of mirikizumab in patients with moderately to severely active CD was consistent with the known safety profile in patients with UC. The frequency of serious adverse events was greater in placebo than mirikizumab. The most common adverse events were upper respiratory tract infections, injection site reactions, headache, and rash.¹

About Omvoh^®

Omvoh^® (mirikizumab) is an interleukin-23p19 (IL-23) antagonist indicated for the treatment of moderately to severely active UC and CD in adults. Omvoh^® selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to overactivation of the IL-23 pathway plays a critical role in the pathogenesis of CD, a chronic, IBD associated with progressive bowel damage, disability and decreased health-related quality of life.

For more information about Omvoh^®, please refer to the product monograph on Lilly.ca.

About Lilly

Lilly is a medicine company turning science into healing to make life better for people around the world. Lilly has been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Lilly's Canadian Affiliate, Eli Lilly Canada Inc. was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially available insulin.

Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.

To learn more about Lilly Canada, visit Lilly.com/en-CA, or follow us on LinkedIn. 

Omvoh^® and its delivery device base are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

References:

	1. Omvoh^® Product Monograph.
	2. Lilly reports one-year histologic outcomes in Phase 3 study of mirikizumab compared to ustekinumab for Crohn's disease. News release. Eli Lilly. October 14, 2024. Accessed January 16, 2025. https://www.prnewswire.com/news-releases/lilly-reports-one-year-histologic-outcomes-in-phase-3-study-of-mirikizumab-compared-to-ustekinumab-for-crohns-disease-302274325.html
	3. Ferrante, Marc, et al. "Efficacy and Safety of Mirikizumab in Patients with Moderately-to-Severely Active Crohn's Disease: A Phase 3, Multicentre, Randomised, Double-Blind, Placebo-Controlled and Active-Controlled, Treat-Through Study." The Lancet, 21 Nov. 2024, https://doi.org/10.1016/S0140-6736(24)01762-8

SOURCE Eli Lilly Canada Inc.

Media Contact: Jason Haug, Eli Lilly Canada Inc., [email protected], [phone]