Baishi Meishi Guibao oral S1P subject regulator Zeposia EU application for new...

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), BMS announced recently.
now, the EMA has initiated a centralized review process.
if approved, Zeposia will be the first oral arginol-1-phosphate (S1P) regulator to treat ulcerative colitis (UC).
application is based on the results of the Key 3 TRUE NORTH Study (NCT02435992).
this is a placebo-controlled study that assesses the efficacy and safety of Zeposia as an induction and maintenance therapy for moderate to severe UC adult patients.
results showed that the study reached two main endpoints: Zeposia's clinical remission results induced in week 10 of the induction period, and the results of maintaining clinical remission in week 52 of the maintenance period were highly statistically significant and clinically significant improvements compared to placebos.
overall security observed in this study is consistent with known security in Zeposia approved labels.
it is worth noting that, based on the results of this study, Zeposia was the first oral acetaminophen-1-phosphoric acid (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, and 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
Centennia.
this 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.
the induction period, Patients in Queue 1 were randomly assigned at a 2:1 scale to receive Zeposia or placebo once a day for 10 weeks.
queue 2 is an open label group, and the purpose of the study being included in the queue is to have a sufficient number of patients for the maintenance period.
2 patients received Zeposia once a day for 10 weeks.
For patients who received Zeposia therapy during the maintenance period, queue 1 or queue 2, who achieved clinical remission in the 10th week 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 in week 10 were still receiving a placebo during double-blind maintenance.
all eligible patients were included in an open label extension trial that was under way to assess the long-term efficacy of moderate to severe UC in Zeposia's treatment.
the main endpoint of the study was 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. The
secondary endpoints include 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 in week 10 who maintained clinical remission at week 52.
data show that the study reached two main endpoints: induced clinical remission in week 10 of induction and maintenance of clinical remission in week 52 of the maintenance period all showed results of high statistically significant (p<0.0001).
addition, in the 10th week of induction and the 52nd week of maintenance, the study also reached a critical secondary endpoint of clinical response and endoscopic improvement.
, Zeposia's safety was consistent with those reported in previous trials.
, Shishi Shiguibao is also conducting Phase III YELLOWSTONE clinical trials 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).
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 are not responding at all to the treatments currently available.
estimates that 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.
March, Zeposia received FDA approval to treat adult multiple sclerosis (RMS), including clinical isolation syndrome, relapse relapse remission, and active secondary progressive disease.
May this year, Zeposia was approved by the European Commission for the treatment of adult patients with relapsed-remission-relieving 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's attack on neuromalies.
immune surveillance function of patients is maintained due to the special action of ozanimod.
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 multiple immune diseases through the combination of the two mechanisms of "injury reduction and enhanced repair".
currently, Pepsi Isaac is developing Zeposia for a variety of immuno-inflammatory adaptations, including Crohn's disease (CD) in addition to multiple sclerosis and ulcerative colitis (UC).
mechanism for treating UC with Zeposia is unclear, but may be associated with reducing the entry of lymphocytes into the inflammatory intestinal mucous membranes.
original source: European Medicines Agency Validates Bristol Myers Squibb's application for Zeposia (ozanimod) for The Treatment of Ulcerative Colitis This article was originally published from Bio Valley, for more information please download Bio Valley APP (Ozanimod)