Lilly Canada and the pan-Canadian Pharmaceutical Alliance (pCPA) successfully complete negotiations for OMVOH® (mirikizumab) for adults with moderately to severely active ulcerative colitis (UC)

TORONTO, Sept. 3, 2024 /CNW/ - Eli Lilly Canada Inc. (Lilly Canada) announced today that it successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for Omvoh^® (mirikizumab) for ulcerative colitis (UC) on August 29, 2024, with a letter of intent (LOI). Omvoh is the first and only interleukin-23p19 (IL-23p19) antagonist approved in Canada for the treatment of moderately to severely active UC and is indicated for adult UC patients who have had an inadequate response, loss of response, or were intolerant to conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.

The successful pCPA negotiation for Omvoh is a key step toward making this medicine publicly accessible to UC patients in Canada. pCPA negotiations typically begin after a recommendation from Canada's Drug Agency (CDA-AMC) and/or Québec's L'Institut national d'excellence en santé et en services sociaux (INESSS). Following a successful negotiation, the pCPA issues an LOI, which sets the terms of the agreement between the pCPA and the drug manufacturer.

This announcement highlights the urgency to swiftly proceed with the next steps of public drug reimbursement, particularly having Omvoh included in the provincial, territorial, and federal drug formularies. Lilly Canada is eager and committed to working with these key stakeholders to ensure that patients living with moderately to severely active UC in Canada have public access to Omvoh regardless of where they live across the country.  

"We are thrilled to conclude a successful negotiation of Omvoh for ulcerative colitis (UC) with the pan-Canadian Pharmaceutical Alliance," said Ken Custer, General Manager of Lilly Canada. "Ensuring timely and broad access to new innovative medicines in Canada is essential for patients to have options to manage their health. We look forward to working with provincial, territorial, and federal public drug programs with the goal of accelerating public access to Omvoh for Canadians living with UC."

About ulcerative colitis (UC)

UC is a disease that affects the colon (large intestine), including the rectum and anus, and inflames the inner lining of bowel tissue, causing symptoms including abdominal pain and cramping; severe diarrhea; rectal bleeding; blood in stool; weight loss; feelings of bowel urgency; and diminished appetite. The disease can disrupt the body's ability to digest food, absorb nutrition, and healthily eliminate waste.¹ UC is a chronic debilitating disease that 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.²

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 ulcerative colitis (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. 

Omvoh received authorization from Health Canada on July 20, 2023³, and subsequently was positively recommended by Canada's Health Technology Assessment bodies, including Canada's Drug Agency (CDA-AMC) on November 16, 2023⁴, and Quebec's L'Institut national d'excellence en santé et en services sociaux (INESSS) on November 29, 2023⁵.

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.ca, or follow us on LinkedIn. 

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

References

^1	Crohn's and Colitis Canada. What are Crohn's and Colitis.
^2	Lilly Canada. Press Release: Lilly's Omvoh^TM (mirikizumab) Now Available in Canada - A First-In-Class Treatment For Adults With Moderately To Severely Active Ulcerative Colitis
^3	Health Canada. Drug and Health Product Portal. Summary Basis of Decision for Omvoh.
^4	Canada's Drug Agency (CDA-AMC). Reimbursement Reviews: Mirikizumab.
5	L'Institut national d'excellence en santé et en services sociaux (INESSS). https://www.inesss.qc.ca/en/themes/medicaments/drug-products-undergoing-evaluation-and-evaluated/extract-notice-to-the-minister/omvoh-colite-ulcereuse-6648.html

SOURCE Eli Lilly Canada Inc.

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