LILLY'S OMVOH™ (MIRIKIZUMAB) NOW AVAILABLE IN CANADA - A FIRST-IN-CLASS TREATMENT FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

• Omvoh achieved all primary and key secondary endpoints, including sustained clinical remission in pivotal trials
• Omvoh delivered significant improvement in bowel urgency, reported by people with ulcerative colitis (UC) as one of the most disruptive symptoms
• This will be Lilly's first entrance into gastroenterology, with the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active UC approved in Canada.

TORONTO, Oct. 17, 2023 /CNW/ - Eli Lilly Canada Inc. announced today that Omvoh^TM (mirikizumab) is now available in Canada for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response, or were intolerant to conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor. Health Canada issued a Notice of Compliance (NOC) for Omvoh on July 20, 2023.

Omvoh is the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active UC approved in Canada.

"We are so pleased to learn of Omvoh, with its unique mechanism of action, being approved in Canada for those living with ulcerative colitis," said Gail Attara, Chief Executive Officer of the Gastrointestinal Society (www.badgut.org). "Compared to other inflammatory conditions, ulcerative colitis has very few medications, so the introduction of Omvoh as a new option is excellent news."

Lori Radke, President and CEO, Crohn's and Colitis Canada said: "Crohn's and Colitis Canada always welcomes new treatments for people with ulcerative colitis in Canada. Ulcerative colitis is a chronic 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 in Canada today. This disease is complex and often requires a personalized approach and multiple treatment options to achieve remission."

Health Canada's approval was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled phase 3 clinical trials, consisting of one 12-week induction study (LUCENT-1) and one 40-week maintenance study (LUCENT-2) for 52 weeks of continuous treatment.

In the LUCENT-1 induction study, 1,162 patients were included in the primary efficacy population. Patients were randomized 3:1 to receive Omvoh (300 mg) intravenous (IV) or placebo IV every 4 weeks for 12 weeks. After 12 weeks of treatment with Omvoh, 24.2 per cent (n=210/868) of patients achieved the primary endpoint of clinical remission compared to 13.3 per cent (n=39/294) of placebo.

Patients who achieved clinical response (63.5 per cent, n=551/868) with Omvoh in LUCENT-1 were re-randomized 2:1 to receive Omvoh (200 mg) subcutaneous (SC) injection or placebo SC injection every 4 weeks for another 40 weeks in LUCENT-2. Of the LUCENT-1 patients who achieved clinical response at 12 weeks, 49.9 per cent (n=182/365) achieved the primary endpoint of clinical remission and 43.3 per cent (n=158/365) achieved histologic-endoscopic mucosal remission at one year, compared to placebo (25.1 per cent, n=45/179 and 21.8 per cent, n=39/179 for clinical remission and histologic-endoscopic mucosal remission, respectively). Omvoh also met all other major secondary endpoints in the LUCENT-2 study.

A novel, patient-centric, 11-point scale developed by Lilly was used to assess changes in bowel urgency response. Among patients who achieved clinical response in the 12-week induction study and who had a baseline urgency severity of 3 or greater, more than two in five patients on Omvoh (42.9%, n=144/336) achieved resolution or near resolution of bowel urgency at one year compared to one in four on placebo (25%, n=43/172, p<0.001).

The Phase 3 LUCENT clinical program also evaluated the safety profile of Omvoh. Few patients discontinued treatment due to adverse events and the majority of treatment-emergent adverse events were mild or moderate in severity. The most frequently reported adverse reactions were upper respiratory tract infections, headache, arthralgia, rash and injection site reactions.

"I am delighted to see a new treatment option available to my patients with ulcerative colitis," said Dr. John Marshall, Professor of Medicine, and Director of the Division of Gastroenterology at McMaster University. "There is a large unmet need for treatments that are effective and safe, and which address symptoms important to patients. Mirikizumab is a welcome addition to our therapeutic armamentarium."

"Driven by innovative science, and the prospect of treating symptoms that matter most to patients, Omvoh is the first and only IL-23p19 antagonist for the treatment of moderately to severely active ulcerative colitis approved in Canada," said Kenneth Custer, General Manager of Lilly Canada. "Health Canada's Notice of Compliance represents an important milestone in the treatment of ulcerative colitis in Canada, and further demonstrates Lilly's commitment to addressing the unmet needs of people with a broad range of autoimmune diseases globally."

About Omvoh 

Omvoh (mirikizumab) is an interleukin-23p19 antagonist indicated for the treatment of moderately to severely active ulcerative colitis in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of UC. Treatment with Omvoh starts with a 300-mg IV infusion, once every four weeks for a total of three infusions, and transitions to two, 100-mg SC self-injections every four weeks during maintenance treatment. 

About Lilly Canada

Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada 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. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.

Omvoh is a trademark owned or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

SOURCE Eli Lilly Canada Inc.

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