Bristol Myers Squibb Receives EC Approval for Zeposia (ozanimod) as First Oral S1P Receptor Modulator for Ulcerative Colitis in the EU
Nov 24, 2021 05:09
CST Updated
05:09
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The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Ulcerative Colitis (UC, Image Source: healthjade.com)
News on November 24, 2021 /BioValleyBIOON/ -- Bristol-Myers Squibb (BMS) recently announced that the European Commission (EC) has approved a new indication for the anti-inflammatory drug Zeposia (ozanimod): for the treatment of moderate to severe active disease in patients who have had an inadequate response, lost response, or were intolerant to conventional therapies or biologics.Ulcerative Colitis (UC)Adult patients.Zeposia is an oral medication taken once daily. The drug is a sphingosine-1-phosphate (S1P) receptor modulator that selectively binds with high affinity to S1P subtypes 1 (S1P1) and 5 (S1P5).. In the United States and the European Union, Zeposia has been previously approved for the treatment ofMultiple Sclerosis（multiple sclerosis，MS）。
It is worth mentioning that,Zeposia is the first and only oral sphingosine-1-phosphate (S1P) receptor modulator approved in the EU for the treatment of ulcerative colitis (UC)., represents a new approach to treating this chronic immune-mediated disease. In the United States,Zeposia was approved in May 2021 as the first oral S1P receptor modulator in the United States for the treatment of UC., This medicine is suitable for treating adult patients with moderate to severe active UC. For this indication, Bristol-Myers Squibb has submitted to the United StatesFDASubmitted a Priority Review Voucher (PRV) to expedite the review.
The approval of Zeposia for the new indication in treating UC is based on the results of the pivotal Phase 3 TRUE NORTH study (NCT02435992). This was a placebo-controlled study that evaluated the efficacy and safety of Zeposia as both an induction and maintenance therapy for adult patients with moderate to severe UC. The results showed that, compared to the placebo group,The Zeposia treatment group showed significant improvements in all primary and secondary efficacy endpoints at weeks 10 and 52, including clinical remission, clinical response, endoscopic improvement, and endoscopic histologic mucosal improvement.The overall safety observed in the study is consistent with the known safety profile in the approved labeling for Zeposia.
Bristol-Myers SquibbImmunology"Jonathan Sadeh, M.D., Senior Vice President of Fibrosis Development, stated: 'The European Commission's approval of Zeposia for the treatment of ulcerative colitis provides physicians and patients with a once-daily oral treatment option. Zeposia has demonstrated robust efficacy and safety, with a mechanism of action distinct from other therapies. We look forward to bringing this new treatment to eligible patients in Europe, significantly alleviating symptoms and achieving sustained clinical remission.'"
TRUE NORTH Study (NCT02435992) is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial that evaluated the efficacy and safety of Zeposia as both induction and maintenance therapy in adult patients with moderate to severe UC. The results showed thatThe study met two primary endpoints: at Week 10 of the induction period and Week 52 of the maintenance period, Zeposia demonstrated highly statistically significant and clinically meaningful improvements compared to placebo in both primary and key secondary endpoints.
——At Week 10 of the induction period (Zeposia group n=429 vs placebo group n=216), the trial met the primary endpoint of clinical remission (18% vs 6%, p<0.0001) as well as key secondary endpoints, including clinical response (48% vs 26%, p<0.0001), endoscopic improvement (27% vs 12%), and endoscopic histologic mucosal improvement (13% vs 4%, p<0.001).
——At Week 52 of the maintenance period (Zeposia group n=230, placebo group n=227), the trial met its primary endpoint of clinical remission (37% vs 19%, p<0.0001) as well as key secondary endpoints, including clinical response (60% vs 41%, p<0.0001), endoscopic improvement (46% vs 26%, p<0.001), corticosteroid-free clinical remission (32% vs 17%), and endoscopic histologic mucosal improvement (30% vs 14%, p<0.001). In patients treated with Zeposia, reductions in rectal bleeding and stool frequency subscores were observed as early as Week 2 (i.e., one week after completing the required 7-day dose titration).
According to the study results, Zeposia is the first oral S1P receptor modulator to demonstrate clinical benefits in treating moderate to severe UC in a phase 3 study. The overall safety observed in the study is consistent with the known safety profile in Zeposia's approved labeling.
Ozanimod Molecular Structure (Source: Wikipedia)
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD), characterized by abnormal immune responses, prolonged duration, and long-term inflammation and ulcers in the mucosa (lining) of the large intestine (colon). Symptoms include bloody stools, severe diarrhea, and frequent abdominal pain, which usually develop over time rather than suddenly. UC significantly impacts patients' health-related quality of life, including physical function, social and emotional well-being, and work capacity. Many patients respond inadequately or not at all to currently available therapies. It is estimated that 12.6 million people worldwide suffer from IBD.
The active pharmaceutical ingredient ozanimod in Zeposia is an oral sphingosine-1-phosphate (S1P) receptor modulator that selectively binds with high affinity to S1P subtypes 1 (S1P1) and 5 (S1P5).
In March 2020, Zeposia was approved by the United States.FDAApproved for the treatment of adult relapsing multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. In May 2020, Zeposia received approval from the European Commission for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) who have active disease (defined as: having clinical or imaging features).
Currently, Bristol-Myers Squibb is developing Zeposia for various immune-inflammatory indications, including Crohn's disease (CD) in addition to multiple sclerosis (MS) and ulcerative colitis (UC). Phase III YELLOWSTONEClinical TrialThe project is evaluating Zeposia for the treatment of patients with moderate to severe active CD. The mechanism of Zeposia in treating UC and CD is still unclear but may be related to reducing lymphocyte infiltration into the inflamed intestinal mucosa. (Bioon.com)
