抗器官排斥药物Envarsus获欧盟委员会批准
2014年7月28日，丹麦Veloxis制药公司和意大利Chiesi制药公司联合宣布，欧盟委员会（EC）已批准抗器官排斥药物（原名LCP-Tacro），用于成人肾脏和肝脏移植者，预防器官排斥反应。
Envarsus的获批，是基于在稳定的肾脏移植者中开展的III期3001研究、在新生肾移植受者中开展的3002研究、以及在肾脏移植和肝脏移植患者中开展的一项广泛的I期和II期临床项目的有利数据。
研究3001和3002表明，envarsus每天给药一次并不逊色于每日两次剂量目前领先的器官移植，普乐可复（他克莫司）。第一阶段和第二阶段的疗效的药代动力学数据，在MAA提交启用外推到肾和肝移植受者更广泛的人群。
目前，在欧盟每年约有20000例肾移植和7000例肝脏移植手术。
XR的器官排斥反应的肾移植患者的预防是通过美国FDA的监管审查，并有一个活动在2014年10月30日行动日期。veloxis并不期望在美国接受额外的肝指示veloxis并不期望在美国接受额外的肝指示envarsusXR获得孤儿药指定由美国FDA接受同种异体肾移植患者的器官排斥反应的预防。
此外，Veloxis已向FDA提交了EnvarsusXR的新药申请（NDA），寻求批准用于肾脏移植者预防器官排斥，目前正在接受FDA的审查，同时FDA已指定该药的处方药用户收费法（PDUFA）目标日期为2014年10月30日。此前，FDA已授予EnvarsusXR孤儿药地位，用于同种一体肾移植患者，预防器官排斥。
Envarsus XR（他克莫司缓释片）， (Tacrolimus)
| Name | Envarsus |
|---|---|
| INN or common name |
tacrolimus |
| Therapeutic area | Graft Rejection |
| Active substance |
tacrolimus |
| Date opinion adopted | 22/05/2014 |
| Company name |
Chiesi Farmaceutici S.p.A. |
| Status | Positive |
| Application type | Initial authorisation |
•Envarsus® (LCP-Tacro) is Veloxis' lead product candidate for suppression of the immune response to prevent the rejection of transplanted organs (immunosuppression)
•Positive top-line results from a clinical phase III study in newly operated kidney transplanted patients (de novo) were announced June 2013
◦Envarsus®, once-daily, demonstrated non-inferiority to Prograf®, twice-daily, based on the composite endpoint of treatment failure at one year (Envarsus® 18.3%, Prograf® 19.6%)
◦Treatment failure rates through the first three months after transplant were 10.4% for Envarsus® and 14.2% for Prograf®
◦Similar incidence of adverse events and impact on laboratory results reported for Envarsus® and Prograf®
•Positive top-line results from clinical phase III study in stable kidney transplant patients were announced June 2011
•In April 2013, Veloxis submitted a marketing authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market Envarsus® for the prevention of organ rejection in kidney transplant patients in the European Union
•In December 2013, the company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® in the U.S.
•Envarsus® has been granted Orphan Drug status by the FDA
•Envarsus® will be a branded primary immunosuppressant drug not automatically substitutable by generics
•In 2010, more than 50,000 organ transplants were conducted in the United States, Japan, the United Kingdom, France, Germany, Italy and Spain