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▎Bristol-Myers Squibb (BMS), editor of WuXi AppTec's content team, announced today that the US FDA has approved Zeposia (ozanimod) 0.
92 mg for the treatment of moderate to severe active ulcerative colitis (UC) in adults.
The press release states that this is the first oral S1P receptor modulator approved for the treatment of patients with moderate to severe active UC.
This approval is based on the results of a pivotal Phase 3 clinical trial called True North.
Compared with placebo, Zeposia significantly improved clinical remission at the 10th week of the induction treatment period (18.
4% vs.
6.
0%; p<0.
0001) and at the 52nd week of the maintenance treatment period (37.
0% vs.
18.
5%; p<0.
0001) ( The proportion of patients with clinical remission) reached the primary endpoint of the trial.
At the same time, Zeposia reached a number of key secondary endpoints including clinical response, endoscopic improvement, and endoscopic-histological mucosal improvement.
Ulcerative colitis is a chronic inflammatory bowel disease (IBD), which is characterized by a long-term abnormal immune response that leads to persistent inflammation and ulcers in the mucous membrane of the colon or rectum.
Symptoms include bloody stools, severe diarrhea, and frequent abdominal pain.
Ulcerative colitis has a major impact on the health-related quality of life of patients, including physical function, social and emotional health, and work ability.
Many patients respond insufficiently or do not respond to currently available treatments.
Zeposia (ozanimod) is an oral S1P receptor modulator that binds to S1P receptors 1 and 5 with high affinity.
Zeposia reduces the ability of lymphocytes to leave the lymph nodes and reduces the number of circulating lymphocytes in the peripheral blood.
It has been approved by the FDA for the treatment of multiple sclerosis.
At present, the mechanism of Zeposia in the treatment of ulcerative colitis has not been fully clarified, but it may involve reducing the number of lymphocytes that migrate to the inflamed intestinal mucosa.
"Despite multiple approved therapies, UC patients still have unmet needs and need additional treatment options to help them better manage their diseases.
" Adam, head of the US Department of Cardiovascular, Immunology and Oncology, Bristol-Myers Squibb Company Mr.
Lenkowsky said: "We are very happy that scientific research in immunology can bring UC patients a new treatment option that is different from the existing therapies.
" References: [1] US Food and Drug Administration Approves Bristol Myers Squibb's Zeposia® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis.
Retrieved May 27, 2021, from Note: This article aims to introduce The progress of medical and health research is not a treatment recommendation.
If you need guidance on the treatment plan, please go to a regular hospital for treatment.
92 mg for the treatment of moderate to severe active ulcerative colitis (UC) in adults.
The press release states that this is the first oral S1P receptor modulator approved for the treatment of patients with moderate to severe active UC.
This approval is based on the results of a pivotal Phase 3 clinical trial called True North.
Compared with placebo, Zeposia significantly improved clinical remission at the 10th week of the induction treatment period (18.
4% vs.
6.
0%; p<0.
0001) and at the 52nd week of the maintenance treatment period (37.
0% vs.
18.
5%; p<0.
0001) ( The proportion of patients with clinical remission) reached the primary endpoint of the trial.
At the same time, Zeposia reached a number of key secondary endpoints including clinical response, endoscopic improvement, and endoscopic-histological mucosal improvement.
Ulcerative colitis is a chronic inflammatory bowel disease (IBD), which is characterized by a long-term abnormal immune response that leads to persistent inflammation and ulcers in the mucous membrane of the colon or rectum.
Symptoms include bloody stools, severe diarrhea, and frequent abdominal pain.
Ulcerative colitis has a major impact on the health-related quality of life of patients, including physical function, social and emotional health, and work ability.
Many patients respond insufficiently or do not respond to currently available treatments.
Zeposia (ozanimod) is an oral S1P receptor modulator that binds to S1P receptors 1 and 5 with high affinity.
Zeposia reduces the ability of lymphocytes to leave the lymph nodes and reduces the number of circulating lymphocytes in the peripheral blood.
It has been approved by the FDA for the treatment of multiple sclerosis.
At present, the mechanism of Zeposia in the treatment of ulcerative colitis has not been fully clarified, but it may involve reducing the number of lymphocytes that migrate to the inflamed intestinal mucosa.
"Despite multiple approved therapies, UC patients still have unmet needs and need additional treatment options to help them better manage their diseases.
" Adam, head of the US Department of Cardiovascular, Immunology and Oncology, Bristol-Myers Squibb Company Mr.
Lenkowsky said: "We are very happy that scientific research in immunology can bring UC patients a new treatment option that is different from the existing therapies.
" References: [1] US Food and Drug Administration Approves Bristol Myers Squibb's Zeposia® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis.
Retrieved May 27, 2021, from Note: This article aims to introduce The progress of medical and health research is not a treatment recommendation.
If you need guidance on the treatment plan, please go to a regular hospital for treatment.
