VELSIPITY™ Receives Health Canada Approval for Adults with Moderately to Severely Active Ulcerative Colitis (UC) Français
VELSIPITY is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5.
KIRKLAND, QC, April 24, 2024 /CNW/ - Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance (NOC) for VELSIPITY™. A once-daily oral treatment, VELSIPITY is for adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or an advanced treatment. Ulcerative Colitis (UC) is the most common form of inflammatory bowel disease (IBD).i,ii In 2023, there are approximately 320,000 Canadians living with IBD, which includes Crohn's disease and UC.iii IBD is characterized by chronic inflammation of the gastrointestinal (GI) tract and can have significant impact on a patient's overall quality of life.iv,v,vi
"For Canadians living with UC, the condition can be unpredictable and impact their physical, mental and emotional wellbeing. It is not uncommon for patients to explore multiple treatment options before finding relief from their symptoms," said Dr. Remo Panaccione, Professor of Medicine and the Director of the Inflammatory Bowel Disease Unit at the University of Calgary. "The approval of VELSIPITY helps provide a new oral advanced therapy option for those with moderately to severely active UC."
"Symptoms related to ulcerative colitis, such as severe abdominal pain, can have a substantial impact on an individual's quality of life including their psychological and social well-being, as well as their ability to engage in daily activities at work, school, and in their personal life," says Kate Lee, Vice President, Research & Patient Programs at Crohn's and Colitis Canada. "Given that no two cases of ulcerative colitis are identical, there is no universal approach to medication and treatment. This is why access to new treatment options is important for individuals living with UC."
"The approval of VELSIPITY marks an important milestone for eligible Canadians living with moderately to severely active UC and can be a potential tool for patients struggling to achieve remission on conventional therapies," said Frédéric Lavoie, Specialty Care Lead for Pfizer Canada. "Pfizer has a long-standing legacy in the management of inflammation and immunology and is proud to bring this new therapy to Canadians living with UC."
About Ulcerative Colitis
Ulcerative colitis affects the lining of the large intestine and can disrupt a person's ability to digest food, absorb nutrition, and eliminate waste in a healthy manner. vii
Symptoms of UC can include chronic diarrhea, abdominal pain, and blood in the stool as well as extra-intestinal manifestations, such as joint pain. Its impact can span beyond the physical to other aspects of life due to the chronic and unpredictable nature of symptoms.viii,ix,x
UC is a complex disease with no one-size-fits-all approach to treatment.xi Some patients with UC do not respond to their initial medical management plans and can cycle through several different treatments throughout the course of their disease.xii
VELSIPITY is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. VELSIPITY has been approved by the US FDA, as well as the European Medicines Agency (EMA). Regulatory applications for etrasimod in ulcerative colitis have been submitted to countries around the world for review, including Australia, Switzerland, Singapore, Mexico and Russia. The approval of VELSIPITY was based, in part, on the review of the results from a Phase 3 clinical program that evaluated the safety and efficacy of VELSIPITY in UC patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy.1
Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. At Pfizer, we apply science and our global resources to bring therapies to people that help extend and improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products. Every day, Pfizer colleagues work to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, X, Instagram or YouTube.
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i Lynch WD, et al. Ulcerative Colitis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; June 11, 2022. |
ii Lewis JD, et al. Incidence, Prevalence and Racial and Ethnic Distribution of Inflammatory Bowel Disease in the United States. Gastroenterology. 2023;S0016-5085(23)04776-5. |
iv Kobayashi T, et al. Ulcerative Colitis. Nat Rev Dis Primers. 2020;6(1):74. |
v Jairath V, et al. Global burden of inflammatory bowel disease. Lancet Gastroenterol Hepatol. 2020;5(1):2-3. |
vi Armuzzi A, et al. Quality of life in patients with moderate to severe ulcerative colitis and the impact of treatment: A narrative review. Dig Liver Dis. 2021;53(7):803-808. |
vii About Crohn's and Colitis. What are Crohn's and Colitis? https://crohnsandcolitis.ca/About-Crohn-s-Colitis/What-are-Crohns-and-Colitis |
viii Seyedian SS, et al. A review of the diagnosis, prevention and treatment methods of inflammatory bowel disease. J. Med Life. 2019;12(2):113-122. |
ix Armuzzi A, et al. The association between disease activity and patient-reported outcomes in patients with moderate-to-severe ulcerative colitis in the United States and Europe. BMC Gastroenterol. 2020;20(1):18. |
x Ordás I, et al. Ulcerative colitis. Lancet. 2012;380(9853):1606-19. |
xi Chowers Y. One Size Does Not Fit All: The Case for Translational Medicine. Rambam Maimonides Med J. 2019;10(2):e0011. |
xii Gibble TH, et al. Identification of inadequate responders to advanced therapy among commercially-insured adult patients with Crohn's disease and ulcerative colitis in the United States. BMC Gastroenterol. 2023;23(1):63. |
SOURCE Pfizer Canada Inc.
Corporate Affairs Canada, 1-866-9Pfizer (1 866 973-4937), [email protected]
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