安斯泰来他克莫司缓释胶囊（ASTAGRAF XL）获FDA批准

 


2013年7月19日 安斯泰来（Astellas）美国子公司今天宣布，ASTAGRAF XL（他克莫司缓释胶囊，tacrolimus extended release capsules）获FDA批准，与霉酚酸酯（MMF）及皮质类醇联用、结合或无巴利昔单抗（basiliximab）诱导，用于预防成人肾移植受者中的器官排斥。安斯泰来于2012年9月提交了该药的新药申请（NDA）。

在美国，ASTAGRAF XL是首个每日一次的他克莫司制剂，该药作为免疫抑制组合方案中的核心组成部分，为肾移植受者预防器官排斥反应提供了一个很有潜力的疗法。

该药的获批，是基于2项主要的、随机、比较III期临床研究，涉及美国、欧洲、加拿大、南美、澳大利亚、南非等国的1093例患者（545例他克莫司缓释胶囊治疗）。

在2007年，他克莫司缓释胶囊在欧洲获批以商品名Advagraf销售；2008年，该药在日本获批以商品名Graceptor销售。总体而言，他克莫司缓释胶囊已获得了全球73个国家的监管批准，每年经该药治疗的患者数超过14万人。

 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.