Takeda Entervio under-skin preparations are available in China

Pharma recently announced the latest developments in the U.S. development of the sub-skin injection (SC) dosage form intestinal selective biologic agent Entervio (Angie ®, common name: vedolizumab, injection with Vidley pearl monoanti.As mentioned earlier, on December 20, 2019, the Company received a Full Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding a Biological Products Licensing Application (BLA) filed by the Company for the maintenance of entervio SC preparations for the treatment of adult patients with moderate to severe ulcerative colitis (UC).This CRL contains FDA questions about the design and labeling of SC equipment, but is not related to clinical safety and efficacy data and conclusions supporting key trials of Theentyvio SC preparation BLA. CRL is also not related to Entervio intravenous (IV) preparations, which have been licensed in 71 countries worldwide, including the United States and the European Union, and has a total treatment experience of 510,000 patients to date.In August, Takeda held a productive meeting with the FDA to review the company's latest data and seek guidance on other data needs needed to support Entervio SC's approval. During the meeting, Takeda clearly understood the data requirements of SC equipment and is currently working to address these issues. Continuous testing of the SC device takes some time. As a result, Takeda expects to launch Entervio SC preparations in the U.S. market in 2022 for the treatment of moderate to severe UC patients, pending FDA approval.Takeda is confident about the future of Entervio SC preparations in the United States and believes that Enteryvio SC preparations can benefit patients with moderate to severe UC. The company remains committed to working with the FDA to meet patients' needs for this important choice. To date, Entyvio SC preparations have been approved in Australia, Canada, Europe and will go on sale in June 2020;Entyvio is an intestinal selective biological agent whose active drug ingredient vedolizumab is an all-humanized monoclonal antibody, specific antagonist alpha4 beta-7 integrator, which inhibits the binding of alpha4 beta7 integrator to the intestinal mucosa cell adhesion molecule MAdCAM-1. MAdCAM-1 is selectively expressed in the gastrointestinal blood vessels and lymph nodes. Alpha-4 beta-7 integration is expressed in a group of circulating white blood cells that have been shown to play an important role in mediating inflammation in CD and UC diseases.Entyvio vein (IV) preparations were approved by the United States and the European Union in May 2014 for the treatment of moderate to severe active ulcerative colitis (UC) and Crohn's disease (CD) adult patients with inadequate response to conventional treatment or tumor necrosis factor α (TNF alpha) antagonists. Currently, Entyvio intravenous (IV) preparations are available in 71 countries worldwide. UC and CD are the two most common inflammatory bowel diseases (IBDs).In May, Entyvio subsuplisive (SC) preparations were approved by the European Union EC as a maintenance therapy for the treatment of moderate to severe UC and CD adult patients. Entyvio SC products include pre-charged syringes and pre-filled syringes. It is worth mentioning that Entyvio is the only maintenance therapy approved for both IV and SC 2 preparations for UC and CD adult patients, providing patients with more options for treatment.In China, Entyvio IV (Angie's ®, vedolizumab, injectable Videlli pearl monoanti) was approved in March this year for moderate-severe active UC and CD adult patients with inadequate, disoriented or insatiable response to traditional treatments or TNF alpha inhibitors. Entyvio (Angie ®) was included in the first batch of clinically urgently needed new drugs from abroad and received expedite review.Entyvio ® is currently the only intestinal selective biologic agent in the field of inflammatory bowel disease (IBD), and its clinical data show that it can work quickly and achieve long-lasting clinical remission and mucosal healing, while being safe and is a first-line biologic recommended by international guidelines in Europe and the United States.From the inclusion of Angie ® (injection with Vidriju monoanti) in the list of the first clinically in urgent need of new drugs from abroad to its rapid approval, this fully demonstrates the Chinese government's determination to accelerate the introduction of innovative drugs and continuously improve people's healthy lives. The drug's approval in China will provide a new treatment option for a wide range of moderate to severe IBD patients in China. (Bio Valley Bioon .com)