Health Canada Has Approved ZEPOSIA® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis

ZEPOSIA^® is the first and only S1P receptor modulating agent approved for the treatment of ulcerative colitis     

MONTREAL, April 12, 2022 /CNW/ - Bristol Myers Squibb Canada (BMS) today announced that Health Canada has approved ZEPOSIA^® (ozanimod) capsules 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 either conventional therapy or a biologic agent.¹ ZEPOSIA^® is the first and only sphingosine 1-phosphate (S1P) receptor modulator approved in Canada for patients with moderately to severely active UC.

"Today's announcement is good news for Canadians living with ulcerative colitis," said Dr. Brian Feagan, Professor of Medicine at the Schulich School of Medicine & Dentistry, gastroenterologist at London Health Sciences Centre. "With this approval, patients seeking an oral therapy have an effective and safe option, free from injections that can be used earlier on in their treatment course."

ZEPOSIA^® (ozanimod) is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5.^2,3 ZEPOSIA^® reduces the capacity of lymphocytes to migrate from lymphoid tissue, reducing the number of circulating lymphocytes in peripheral blood and lymphocyte migration into the intestines.⁴ It is taken orally as a capsule, once daily, with or without food.⁵ 

"People living with ulcerative colitis often face debilitating symptoms, in addition to significant impacts to their social and emotional well-being. Symptoms are often unpredictable and many people alter their lifestyle not knowing when their disease will flare up," said Lori Radke, President & CEO, Crohn's and Colitis Canada. "Canada has one of the highest rates of inflammatory bowel disease in the world, and for the over 120,000 Canadians living with ulcerative colitis, this new treatment provides an additional and convenient pill-format option to manage and control their chronic disease."

UC is a chronic inflammatory bowel disease (IBD) affecting the large intestine (colon),⁶ causing inflammation (redness and swelling) and ulceration (sores) along the digestive tract which can lead to abdominal pain, cramps, bleeding, diarrhea and other additional symptoms, such as urgency, that can affect the daily lives of those living with the disease.⁷ Most Canadians are diagnosed with IBD before the age of 30,⁸ with UC having a major impact on patients' health-related quality of life, including physical functioning, social and emotional well-being and ability to go to work/school.⁹

"The approval of ZEPOSIA^® for UC brings an important new treatment option for Canadian patients living with chronic and debilitating incurable diseases like ulcerative colitis," said Troy André, General Manager, Bristol Myers Squibb Canada. "At BMS, we continue to be committed to driving innovations that have the potential to transform patients' lives."

Health Canada's approval of ZEPOSIA^® is based on data from the randomized, double-blind, placebo-controlled Phase 3 clinical trial TRUENORTH, evaluating ZEPOSIA^® as an induction and maintenance therapy versus placebo in adult patients with moderately to severely active UC.^10. During induction at Week 10 (ZEPOSIA^® N=429 versus placebo N=216) the trial met its primary endpoint of clinical remission (18% versus 6%, p<0.0001) and a significantly greater proportion of patients treated with ZEPOSIA^® achieved clinical response (48% versus 26%, p<0.0001), endoscopic improvement (27% versus 12%, p<0.0001) and mucosal healing (13% versus 4%, p<0.001) compared to placebo.

During maintenance at Week 52 (ZEPOSIA^® N=230 versus placebo N=227) the trial met its primary endpoint of clinical remission (37% versus 19%, p<0.0001) and a significantly greater proportion of patients treated with ZEPOSIA^® achieved clinical response^b (60% versus 41%, p<0.0001), endoscopic improvement^c (46% versus 26%, p<0.001), mucosal healing^d (30% versus 14%, p<0.001) and corticosteroid-free clinical remission^e (32% versus 17%, p<0.001) compared to placebo.¹¹

About Bristol Myers Squibb Canada

Bristol Myers Squibb Canada Co. is an indirect wholly-owned subsidiary of Bristol Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb global operations, visit www.bms.com. Bristol Myers Squibb Canada Co. delivers innovative medicines for serious diseases to Canadian patients in the areas of cardiovascular health, oncology, and immunoscience. Bristol Myers Squibb Canada Co. employs close to 300 people across the country. For more information, please visit www.bms.com/ca.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.

^a	Clinical remission is defined as: rectal bleeding subscore = 0, stool frequency subscore = 0 or 1 (and a decrease from baseline in the stool frequency subscore of ≥ 1 point), and endoscopy subscore = 0 or 1 without friability.
^b	Clinical response is defined as a reduction from baseline in the 3-component Mayo score of ≥ 2 points and ≥ 35%, and a reduction from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of 0 or 1.
^c	Endoscopic improvement is defined as a Mayo endoscopy subscore of ≤ 1 point without friability.
^d	Mucosal healing is defined as both Mayo endoscopic score ≤ 1 without friability and histological improvement (defined as no neutrophils in the epithelial crypts or lamina propria and no increase in eosinophils, no crypt destruction, and no erosions, ulcerations, or granulation Geboes index score < 2.0)
^e	Corticosteroid-free remission is defined as clinical remission at Week 52 while off corticosteroids for ≥ 12 weeks.

 

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^1	ZEPOSIA® Product Monograph. Bristol Myers Squibb. April 7, 2022.
^2	ZEPOSIA® Product Monograph. Bristol Myers Squibb. April 7, 2022.
^3	Scott FL, Clemons B, Brooks J, et al. Ozanimod (RPC1063) is a potent sphingosine-1-phosphate receptor-1 (S1P1 ) and receptor- (S1P5 ) agonist with autoimmune disease-modifying activity. Br J Pharmacol. 2016;173(11):1778-1792. doi:10.1111/bph.13476
^4	Scott FL, Clemons B, Brooks J, et al. Ozanimod (RPC1063) is a potent sphingosine-1-phosphate receptor-1 (S1P1 ) and receptor- (S1P5 ) agonist with autoimmune disease-modifying activity. Br J Pharmacol. 2016;173(11):1778-1792. doi:10.1111/bph.13476
^5	ZEPOSIA® Product Monograph. Bristol Myers Squibb. April 7, 2022
^6	Canadian Digestive Health Foundation. What is ulcerative colitis. https://cdhf.ca/digestive-disorders/ulcerative-colitis/what-is-ulcerative-colitis/. Accessed March 7, 2022.
^7	Crohn's and Colitis Canada. 2018 Impact of Inflammatory Bowel Disease in Canada. https://crohnsandcolitis.ca/Crohns_and_Colitis/documents/reports/2018-Impact-Report-LR.pdf. Accessed March 7, 2022.
^8	Kaplan G, Bernstein C, Coward S, et al. The Impact of Inflammatory Bowel Disease in Canada 2018: Epidemiology. Journal of the Canadian Association of Gastroenterology. Accessed March 7, 2022.
^9	Rubin D, Ananthakrishnan A, Siegel C, Sauer B, Long M. ACG Clinical Guideline: Ulcerative Colitis in Adults. American Journal of Gastroenterology. 2019;114:384–413. doi:10.1430
^10	ZEPOSIA® Product Monograph. Bristol Myers Squibb. April 7, 2022.
^11	ZEPOSIA® Product Monograph. Bristol Myers Squibb. April 7, 2022.

SOURCE Bristol Myers Squibb Canada Co.

For media requests: David Henein, Account Executive, Health, Edelman, [email protected]; Rachel Yates, Lead, Corporate Affairs, Bristol Myers Squibb Canada, [email protected]