安斯泰來（Astellas）美國子公司今天宣布，ASTAGRAF XL（他克莫司緩釋膠囊，tacrolimus extended release capsules）獲FDA批準(zhǔn)，與霉酚酸酯（MMF）及皮質(zhì)類醇聯(lián)用、結(jié)合或無巴利昔單抗（basiliximab）誘導(dǎo)，用于預(yù)防成人腎移植受者中的器官排斥。安斯泰來于2012年9月提交了該藥的新藥申請（NDA）。
在美國，ASTAGRAF XL是首個(gè)每日一次的他克莫司制劑，該藥作為免疫抑制組合方案中的核心組成部分，為腎移植受者預(yù)防器官排斥反應(yīng)提供了一個(gè)很有潛力的療法。
該藥的獲批，是基于2項(xiàng)主要的、隨機(jī)、比較III期臨床研究，涉及美國、歐洲、加拿大、南美、澳大利亞、南非等國的1093例患者（545例他克莫司緩釋膠囊治療）。
在2007年，他克莫司緩釋膠囊在歐洲獲批以商品名Advagraf銷售；2008年，該藥在日本獲批以商品名Graceptor銷售?？傮w而言，他克莫司緩釋膠囊已獲得了全球73個(gè)國家的監(jiān)管批準(zhǔn)，每年經(jīng)該藥治療的患者數(shù)超過14萬人。
英文原文：Astellas Announces FDA Approval of ASTAGRAF
Astellas Announces FDA Approval of ASTAGRAF XL(TM) (tacrolimus extended-release capsules) for the Prophylaxis of Organ Rejection in Adult Kidney Transplant Recipients
NORTHBROOK, Ill., July 19, 2013 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that the U.S. Food and Drug Administration (FDA) has approved ASTAGRAF XL(TM) (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction.
"Each transplant recipient is different and requires a personalized treatment approach. The approval of ASTAGRAF XL marks an important milestone in post-transplant care as it provides physicians with a new treatment option for kidney transplant recipients," said Sef Kurstjens, M.D., PhD., chief medical officer, Astellas Pharma, Inc. "Astellas is pleased to continue our more than 20-year commitment to the field of transplant immunology."
ASTAGRAF XL is the first once-daily oral tacrolimus formulation available in the U.S. for kidney transplant recipients. ASTAGRAF XL offers a potentially promising treatment option for appropriate kidney transplant recipients as a core component of an immunosuppressive regimen for the prophylaxis of organ rejection.
The two primary, randomized, comparative phase 3 clinical studies to support FDA approval enrolled 1,093 patients (545 on tacrolimus extended-release) in the U.S., Europe, Canada, South America, Australia and South Africa. Astellas was granted marketing approval for tacrolimus extended-release capsules under the trade name Advagraf(R) in Europe in 2007 and under the trade name Graceptor(R) in Japan in 2008. In total, tacrolimus extended-release capsules have been approved for use in 73 countries.
About ASTAGRAF XL (tacrolimus extended-release capsules)
ASTAGRAF XL extended-release capsules is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney transplant. ASTAGRAF XL is an extended-release capsule and is not the same as tacrolimus immediate-release capsules. Your doctor should decide what medicine is right for you.
ASTAGRAF XL is not for use with medicines called cyclosporine (Neoral(R), Sandimmune(R), Gengraf(R)). It is not known if ASTAGRAF XL is safe and effective when used with sirolimus (Rapamune(R)) in people who have had kidney transplants. It is not known if ASTAGRAF XL is safe and effective in children under 16 years of age who have had kidney transplants.
