EMA accepts applications for listing of UC and CD for adult patients with take-field subcutaneous injection type Entyvio (vedolizumab)

recently, Takeda, thegiant ofPharmaceutical(http:// in Japan, announced that the EuropeanPharmaceutical(http://Authority (EMA) had accepted subcutaneous injection form Entyvio (vedolizumab) as a maintenance therapy for adult patients with severe ulcerative colitis (UC) and Crohn's disease (CD) to be listedabout Entyvio
Entyvio is an intestinal selective humanized monoclonal antibody that was approved for marketing in the United States and the European Union in May 2014Currently, Entyvio intravenous fluids are approved in more than 60 countries worldwide for the treatment of adult patients with moderate to severe active ulcerative colitis (UC) or Crohn's disease (CD)Entyvio's activedrug(http://ingredient is vedolizumab, a whole-humanized monoclonal antibody that specifically antagonist alpha 4 beta7 integrators inhibit the combination of alpha4 beta7 copolymer molecule MAdCAM-1MAdCAM-1 is selectively expressed in gastrointestinal blood vessels and lymph nodesAlpha4 beta7 integrators are expressed in a group of circulating white blood cells that have been shown to play an important role in the process of acmediation inflammation of CD and UC diseasesThe MAA submission is based on data from the key Phase III VISIBLE-1 study The study was a randomized, double-simulated, double-blind, placebo-controlled study that included an intravenous infusion (IV) Entyvio control group The study included 383 patients with moderate to severe active UC who were under-reacted to or unresponsive or intolerant of the treatment of glucocorticoids, immunomodulators, or tumor necrosis factors (TNF-alpha) antagonists prior to the study In the study, patients received 2 doses of open label IV Entyvio at week 0 and 2, and patients with clinical remission were randomly assigned to 3 treatment groups in week 6: Entyvio SC (108mg) and placebo IV treatment group (n?106), Entyvio IV (300mg) and placebo SC treatment group (n?54), placeboS-IV treatment group (n-56) Subcutaneous injections are given every 2 weeks and intravenous injections are performed every 8 weeks The main purpose of the study was to assess the efficacy and safety of Entyvio SC as a maintenance therapy 　　The data showed that in the 52nd week of treatment, a statistically significantly higher percentage of patients in the Entyvio SC treatment group achieved clinical remission (46.2% vs 14.3%, p0.001; clinical remission was defined as a Mayo score of 2 points and no single score of 1 point) to reach the main endpoint of the study The Entyvio IV control group observed a similar clinical remission rate (42.6%) 　　In addition, the Entyvio SC treatment group showed statistical superiority at key secondary endpoints compared to the placebo group, including mucosal healing (56.6 percent vs 21.4 percent, p0.001) and persistent clinical remission (64.2 percent vs 28.6 percent, p 0.001) Entyvio SC treatment group was also higher than the placebo group in terms of persistent clinical remission rate (15.1% vs 5.4%, p.076) and corticosteroid-free clinical remission rate (28.9% vs 8.3%, p.067) but not statistically significant Similar results were observed in entyvio IV treatment groups 　　Further subgroup analysis (http:// showed that the clinical remission rate of Entyvio SC was significantly higher than that of placebo in patients who had not previously received (initial treatment) and had received (treatment) tumor necrosis factor-alpha (TNF alpha) (first-time subgroup: 53.7 percent vs 18.9 percent, p 0.001; 　　In terms of safety
adverse events (including severe adverse events and infections) were similar in the Entyvio SC and Entyvio IV treatment groups, with a slight reaction at the injection site, a 9.4% incidence in the Entyvio SC treatment group (0% in the placebo group), and no patients stopped treatment Antientyvio antibody (AVAs) detection rates were similar in entyvio SC and IV groups (5.7% and 5.6%, respectively)