On November 23, 2021, Bristol-Myers Squibb announced that the European Commission has approved marketing authorization for Zeposia (ozanimod) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have an inadequate response, loss of response, or intolerance to conventional treatments or biologics. Zeposia, a once-daily oral medication, is a sphingosine-1-phosphate (S1P) receptor modulator that selectively binds with high affinity to S1P subtypes 1 (S1P1) and 5 (S1P5). Zeposia is the first and only oral S1P receptor modulator approved for UC and represents a new approach to treating this chronic immune-mediated disease.
(Source: Internet)
The approval is based on data from True North, a pivotal Phase 3 trial investigating Zeposia as induction and maintenance therapy versus placebo in adults with moderately to severely active UC. Key findings from the trial include:
At week 10 of induction therapy (Zeposia N=429 vs. placebo N=216), the trial met its primary endpoint of clinical response as well as key secondary endpoints of clinical response, endoscopic improvement, and endoscopic histological mucosal improvement (Zeposia vs. placebo).
The trial met its primary endpoint of clinical response at 52 weeks of maintenance treatment (Zeposia N=230 vs. placebo N=227), as well as key secondary endpoints including clinical response, endoscopic improvement, corticosteroid-free clinical response, and endoscopic histological mucosal improvement (Zeposia vs. placebo). In patients treated with Zeposia, reductions in rectal bleeding and stool frequency subscores were observed as early as Week 2 (i.e., 1 week after completion of the required 7-day dose titration).
In the induction and maintenance treatment phases of the True North trial, the overall safety profile was consistent with the known safety profile of Zeposia and in patients with moderate-to-severe UC.
"True Results from the North trial showed that Zeposia demonstrated significant, durable efficacy in patients with moderate-to-severe ulcerative colitis across multiple key endpoints of clinical improvement, endoscopic and mucosal healing, and clinical remission. The results of endoscopic improvement and histologic remission are particularly meaningful because they are difficult to achieve, suggesting that Zeposia has the potential to be an effective and safe oral treatment option for clinicians treating adult patients with this severe chronic disease."
Luisa Avedano, CEO of the European Federation of Crohn's and Ulcerative Colitis Societies, said: "More than three million people in Europe are affected by inflammatory bowel disease, including ulcerative colitis, which is a challenging and often debilitating condition. We are pleased that we have provided such patients and their caregivers with a new treatment option that can control disease symptoms to improve their quality of life."
References:
https://investors.bms.com/iframes/press-releases/press-release-details/2021/Bristol-Myers-Squibb-Receives-European-Commission-Approval-of-Zeposia-ozanimod-for-use-in-Adults-with-Moderately-to-Severely-Active-Ulcerative-Colitis/default.aspx
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