21 July 2025
Eli Lily Canada Inc. received approval from Health Canada for Omvoh® (mirikizumab) for CD. It will be available soon for Canadian patients. This drug is an interleukin-23p19 antagonist used for the treatment of adult patients having moderate to severe active CD. Including results of loss of response, intolerance, and inadequacy to the conventional therapy or any biologic treatment. Health Canada has additionally approved a new citrate-free formulation of Omvoh for subcutaneous injection to the already present UC indicated and new CD indication. The new therapy is an advancement and solution in Canada’s healthcare market and a contribution to curing CD diseases.
The authorization of this drug was based on the validation of its VIVID-1 clinical study, which consisted of over 1000 adult participants. Under VIVID-1, mirikizumab showed valid clinical efficacy meeting multiple endpoints in comparison with placebo in moderate to severe active CD patients. It also meets coprimary composite endpoints, including key secondary endpoints. The coprimary endpoints consist of patient-reported outcomes (PRO), a clinical response in week 12, and in week 52, providing an endoscopic response. Also, Crohn’s disease activity index (CDAI) clinical remission reports are available in 52 weeks. The response rate to the respective diseases and the calculation according to the nature of the study showed statistical growth. The statistical performance was also noticed in subgroups with and without the failure of biological therapies, which was the parameter for the coprimary and secondary endpoints.
President and General Manager of Lily Canada, Mathilde Merlet, said, “We are proud to witness the presence of Omvoh in the market, as it will be the safest option for treatments. The additional indication will strengthen our commitment to support the IBD community, and we are excited to showcase our new citrate-free formulation that we believe will enhance patient experience.”
Interim President & CEO of Crohn’s and Colitis Canada, Sylvain Chiasson, said, “We are always welcoming to the new treatments for individuals with CD in Canada. CD is a chronic autoimmune diseases that instigate the immune system to attack the gastrointestinal system. It is one of the critical diseases that has increased surgeries, hospitalizations and surgeries and has impacted the lives of 162,000 Canadians. Due to the risk, not every individual reacts the same way to the available treatments. So, this medication is good news for us and an addition to therapies for CD.”
21 July 2025
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