VELSIPITY Receives Health Canada Approval for Adults with Moderately to Severely Active Ulcerative Colitis (UC)

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

About VELSIPITY

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