The world's only intestinal selective anti-inflammatory drug! Takeda Enteryvio (Anjiyou) subskin preparation u.S. project update, intravenous preparations listed in China!

September 03, 2020 // -- Takeda Pharma recently announced the latest developments in the U.S. development of subsutaneous injection (SC) dosage form intestinal selective biologic agent Entervio (Angie's ®, generic name: vedolizumab, injection with Vidliju monomatics).
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 product licensing application (BLA) filed by the company for the maintenance of entervio SC preparations for adult patients with moderate to severe ulcerative colitis (UC).
the CRL contains FDA questions about the design and labeling of SC devices, 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 around the world, including the United States and the European Union, with an overall treatment experience of 510,000 patients to date.
August, Takeda held a productive meeting with the FDA to review the company's latest data and seek guidance on other data requirements needed to support Entervio SC approval.
meeting, Takeda had a clear understanding of the data requirements of SC equipment and was working to address those issues.
continuous testing of the SC device will take some time.
, Takeda expects to launch Entervio SC in the U.S. market in 2022 for the treatment of moderate to severe UC patients, pending FDA approval.
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.
company remains committed to working with the FDA to meet patients' needs for this important choice.
so far, Entyvio SC preparations have been approved in Australia, Canada, Europe and will go on sale in June 2020;
two common inflammatory bowel diseases (IBD, pictured: tsukuba.ac.jp) Entyvio is an intestinal selective biological agent whose active drug ingredient vedolizumab is an all-humanized monoclonal antibody, specific antagonist alpha-4 beta-7 integrator, which inhibits the binding of alpha-4 beta-7 to the intestinal mucosa cell adhesive molecule AdCAM-1.
MAdCAM-1 is selectively expressed in gastrointestinal blood vessels and lymph nodes.
alpha-4 beta-7 integratives are 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 venous (IV) preparation was 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 who do not respond well to conventional treatments or tumor necrosis factor alpha (TNF alpha) antagonists.
, Entyvio intravenous (IV) preparations are available in 71 countries worldwide.
UC and CD are the two most common inflammatory bowel diseases (IBDs).
May this year, 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 noting 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 Vedolizumab) was approved in March this year for moderate-severe active UC and CD adult patients with inadequate, disoriented or insuperable response to traditional treatments or TNF alpha inhibitors.
entered the first batch of clinically in urgent need of new drugs from abroad® and received an 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 biological agent recommended by international guidelines in Europe and the United States.
From the inclusion of Angie You ® (Injection 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.
the original source: Update on the U.S. Development Program for the Investigational Subcutaneous Development of ENTYVIO (vedolizumab) as a Maintenance Therapy in Adults with Moderate to Severe Ulcerative Colitis.