Hundred-time Meishi Shiguibao Zeposia in the European Union formally applied for a new adaptive disorder

(BMS) recently announced that the European Medicines Agency (EMA) has accepted Zeposia's marketing authorization application (MAA) for the treatment of adult patients with moderate to severe ulcerative colitis (UC). The EMA has now started the centralized review process. If approved, Zeposia will be the first oral acetaminophen-1-phosphoric acid (S1P) regulator for the treatment of ulcerative colitis (UC).This application is based on the results of the Key 3 TRUE NORTH Study (NCT02435992). This is a placebo-controlled study that evaluates the efficacy and safety of Zeposia as an induction and maintenance therapy for moderate to severe UC adult patients. The results showed that the study reached two main endpoints: Zeposia's clinical remission results induced in week 10 of the induction phase, and the results of maintaining clinical remission in week 52 of the maintenance period were highly statistically significant and clinically significant improvements compared to placebo. The overall security observed in this study is consistent with known security in Zeposia approved labels.It is worth mentioning that, according to the results of this study, Zeposia was the first oral acetaminophen-1-phosphate (S1P) regulator to show clinical benefits in the treatment of moderate to severe UC in Phase III studies."Ulcerative colitis is an unpredictable and potentially debilitating disease that many patients use different treatments when trying to control their disease," said Dr. Mary Beth Harler, M.D., head of immunology and fibrosis development at Pepsi. The application is an important step in providing Zeposia to eligible patients in the EU who need new treatment options, proven efficacy and safety, and oral dissipation. TRUE NORTH is a multi-center, randomized, double-blind, placebo-controlled Phase III trial that investigates the efficacy and safety of Zeposia 1mg in moderate to severe UC patients who did not respond well to previous treatments. During the induction period, Patients in Queue 1 were randomly assigned to receive Zeposia or placebo once a day for 10 weeks at a 2:1 scale. Queue 2 is an open label group, and the purpose of the study's inclusion in the queue is to have a sufficient number of patients during the maintenance period. Queue 2 patients receive Zeposia once a day for 10 weeks.For the maintenance period, patients who received Zeposia therapy in Queue 1 or Queue 2 who achieved clinical remission in week 10 of the induction period were reassigned at a 1:1 scale and treated with Zeposia or placebo until week 52. Patients who received placebo therapy during induction and clinical remission at week 10 were still receiving a placebo during double blind maintenance. All eligible patients were included in an open label extension trial, which is ongoing to assess the long-term efficacy of moderate to severe UC in Zeposia's treatment.The main endpoints of the study were the proportion of clinically remission patients based on a comprehensive clinical and endoscopic score (3-component Mayo score) at week 10 of induction and week 52 of maintenance. Secondary endpoints included the proportion of patients who achieved clinical response in weeks 10 and 52, the proportion of patients who achieved endoscopic improvement (endoscopic score ≤1) at week 10 and week 52, and the proportion of patients who achieved clinical remission at week 10 and week 52.The data showed that the study reached two main endpoints: induced clinical remission in the 10th week of induction and maintaining clinical remission in week 52 of the maintenance period all showed results with high statistically significant (p<0.0001). In addition, during the 10th week of induction and the 52nd week of the maintenance period, the study reached a critical secondary endpoint of clinical response and endoscopic improvement. In this study, Zeposia's safety was consistent with those reported in previous trials.At present, Shishi Meishiguibao is also conducting Phase III YELLOWSTONE clinical trial project to evaluate Zeposia's treatment of patients with moderate to severe active Crohn's disease (CD).Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) characterized by abnormal immune response and long duration, long-term inflammation and ulcers (ulcers) in the mucous membranes (linings) of the large intestine (colon). Symptoms include blood stools, severe diarrhea, and frequent abdominal pain, usually over time rather than suddenly. UC has important implications for patients' health-related quality of life, including physical, social and emotional health, and ability to work. Many patients do not respond at all to the treatments currently available. An estimated 12.6 million people worldwide suffer from IBD.Zeposia's active pharmaceutical ingredient, ozanimod, is an oral arginol-1-phosphate (S1P) subject regulator that selectively binds S1P subtypes 1 (S1P1) and 5 (S1P5) with high affinity.In March, Zeposia received FDA approval to treat adult multiple sclerosis (RMS), including clinical isolation syndrome, relapsed remission-relieving diseases, and active secondary progressive diseases. In May, Zeposia was approved by the European Commission for the treatment of adult patients with relapsed-remissive multiple sclerosis (RRMS) with active diseases (defined as clinical or imaging characteristics).In the treatment of multiple sclerosis (MS), ozanimod selective binding to S1P1 is thought to inhibit the migration of activated lymphocytes from a specific subse group to the inflammatory region, reducing the levels of circulating T lymphocytes and B lymphocytes that can lead to anti-inflammatory activity, thereby relieving the immune system from attacking the neuromalics. Due to the special action of ozanimod, the patient's immuno-surveillance function is maintained. The combination of ozanimod and S1PR5 activates specific cells in the central nervous system, promotes myelin regeneration, and prevents synapse defects, ultimately preventing nerve damage. Ozanimod has the potential to improve the symptoms of a variety of immune diseases through the combination of the two mechanisms of "Reducing Injury and Strengthening Repair".Currently, Pepsi-Mercer is developing Zeposia for a variety of immuno-inflammatory adaptations, including Crohn's disease (CD) in addition to multiple sclerosis and ulcerative colitis (UC). The mechanism by which Zeposia treats UC is unclear, but may be associated with reducing the entry of lymphocytes into the inflammatory intestinal mucous membranes. (Bio Valley)original source: European Medicines Agency Validates Bristol Myers Squibb's application for Zeposia (ozanimod) for The Treatment of Ulcerative Colitis