Latest news with #MathildeMerlet
Cision Canada
15-07-2025
- Health
- Cision Canada
Health Canada Approves Lilly's Omvoh® (mirikizumab) for Crohn's Disease; New Citrate-Free Formulation Français
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 ( "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 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 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.
Cision Canada
09-07-2025
- Health
- Cision Canada
ZEPBOUND™ KWIKPEN® (TIRZEPATIDE INJECTION), THE FIRST AND ONLY DUAL RECEPTOR AGONIST FOR THE TREATMENT OF OBESITY, NOW APPROVED AND AVAILABLE IN CANADA Français
ZEPBOUND ™ KwikPen ® is the first and only Health Canada-approved treatment activating two incretin hormone receptors, GIP and GLP-1, to manage obesity or overweight Adults taking tirzepatide injection in a clinical trial lost on average 21.8 kg (48 lbs.) at the highest dose TORONTO, July 9, 2025 /CNW/ - Eli Lilly Canada is pleased to announce that ZEPBOUND ™ KwikPen ® (tirzepatide injection) is now available in Canada, providing a new, innovative treatment for adult Canadians living with obesity or overweight. Health Canada authorized ZEPBOUND ™ KwikPen ® as a once-weekly injection for chronic weight management, as an adjunct to diet and exercise, for adults living with obesity (with a BMI of 30 kg/m 2 or greater), or overweight (with a BMI of 27 kg/m 2 to less than 30 kg/m 2) and also have at least one weight-related medical condition such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease. 1 ZEPBOUND ™ KwikPen ® manages obesity or overweight by activating the GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors. It is the first and only Health Canada-approved dual receptor agonist for chronic weight management, including weight loss and weight maintenance. "The evidence and research are unequivocal, obesity is a chronic disease with severe health implications and when not properly addressed, leads to numerous other chronic conditions, strains health systems, reduces productivity, and increases disability. The impact is too significant to ignore," says Mathilde Merlet, General Manager and President, Lilly Canada. "With ZEPBOUND ™, Lilly is aiming to transform how this disease can be managed and make life better for Canadians living with obesity. " The approval was based on results from the phase 3 SURMOUNT-1, SURMOUNT-2, SURMOUNT-3 and SURMOUNT-4 clinical trials. In SURMOUNT-1, a study in 2,539 adults with obesity, or excess weight and weight-related medical conditions not including diabetes, people treated with tirzepatide injection as an adjunct to diet and exercise experienced significant weight loss compared with placebo at 72 weeks. At the highest dose (15 mg), people treated with tirzepatide injection lost on average 21.8 kg (48 lbs.), while at the lowest dose (5 mg), people lost on average 15.4 kg (34 lbs.) – compared to 3.2 kg (7 lbs.) on placebo. 1 Obesity In Canada One in three Canadians live with obesity 2 - a chronic and progressive disease which is the result of complex interactions between genetic, environmental, behavioural, biological and social factors. 3 It is characterized by abnormal or excessive body fat (also called adiposity) that impairs health, 4 and is associated with more than 200 weight-related health conditions, 5 including heart disease, type 2 diabetes, and many cancers. 4 People living with obesity face substantial bias and stigma, which contribute to increased morbidity and mortality independent of weight or body mass index, and negatively influences the level and quality of care they receive. 5 In fact, more than half (54%) of adults with obesity report being stigmatized by coworkers and almost two-thirds (64%) of adults living with obesity have experienced weight bias from a healthcare professional. 6 Despite its widespread impact, obesity often goes untreated, leading to significant personal, societal, and economic consequences. A failure to recognize and treat obesity as a chronic disease in Canada has driven its economic cost to $27.6 billion—20% higher than previously estimated. 7 The Community Reacts Dr. Sean Wharton, Internal Medicine Physician and Weight Management Specialist: "This will increase the options for weight management. This is a win for Canadians who struggle with obesity and obesity related conditions." Dr Yves Robitaille, Obesity Management Specialist: "Managing obesity often requires medication to reach targets that will improve people's health. Health Canada's approval of tirzepatide for the treatment of this disease allows us to add this tool to our options, thus providing Canadian patients with an effective new medicine to manage their obesity. It is a significant advancement." Lisa Schaffer, Executive Director at Obesity Canada:"Canada is entering a new era in obesity care — one defined by innovation, growing public awareness, and the willingness to challenge outdated thinking. While obesity touches the lives of all Canadians, its impact is not felt equally. What we need now is the courage to act — to build a system where new tools and treatments aren't just available, but truly accessible. Obesity Canada is excited and encouraged to see more organizations, including Eli Lilly Canada, recognizing the complexity of obesity as a chronic disease and joining efforts to change how Canada sees, supports, and understands people affected by obesity." Priti Chawla, Executive Director, Obesity Matters/Parlons Obésité: "The approval of ZEPBOUND ™ KwikPen ® marks a meaningful step forward in recognizing the need for evidence-based treatments for obesity. It signals that Canadians living with obesity are finally being seen, heard, and offered more options to support their health. At Obesity Matters/Parlons Obésité, we believe that access to effective care must be guided by need—not privilege. We call on governments and employers to ensure equitable access to this treatment, free from stigma or judgment. Every Canadian living with obesity deserves the opportunity to thrive." Sandra Elia, Lived Experience Advocate, Obesity Matters/Parlons Obésité:"This is an exciting time in history. For years, people living with obesity have carried the burden of this disease in silence—battling not just the illness, but the stigma, isolation, and judgment that surround it. The approval of ZEPBOUND ™ KwikPen ® is more than a medical advancement—it's a declaration. A declaration that your struggle is real, your journey is valid, and your care must be rooted in respect, compassion, and science. This is not just hope—it's progress. A future where those living with obesity are no longer dismissed, but deeply supported, empowered, and treated with the dignity they have always deserved." About the SURMOUNT clinical trial program The SURMOUNT phase 3 global clinical development program for tirzepatide in chronic weight management began in late 2019 and has enrolled more than 5,000 people with obesity or overweight across six registration studies, four of which are global studies. SURMOUNT-1, SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 were submitted to Health Canada and demonstrated tirzepatide injection significantly reduced body weight compared with placebo in people living with obesity or overweight, with or without type 2 diabetes. About ZEPBOUND ™ KwikPen ® (tirzepatide injection) 1 ZEPBOUND ™ KwikPen ® (tirzepatide injection) is Health Canada-approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI ≥ 30 kg/m 2), or overweight (BMI ≥ 27 kg/m 2) with at least one weight-related comorbid condition. ZEPBOUND ™ KwikPen ® is the first and only Health Canada-approved obesity treatment that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors. ZEPBOUND ™ KwikPen ® (was authorized by Health Canada on May 13, 2025. To view the full ZEPBOUND ™ KwikPen ® product monograph, please visit 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 or follow us on LinkedIn. SOURCE Eli Lilly Canada Inc.
