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            1. 主页 > 乙肝新闻 > 新药研制 >

            阿的福韦

              美国肝联  提供 2002-3-22

              GILEAD公司今天已经正式向FDA提出新药申请上市:阿的福韦-Adefovir Dipivoxil 10mg。研究显示:阿的福韦-Adefovir Dipivoxil 对于e抗原+性,e抗原-性,拉米夫定抗药的乙肝患者几乎统统有效。公司总裁执行官讲,“治疗慢性HBV已经成为世界医疗界当务之急,阿的福韦-Adefovir Dipivoxil 的通过将是治疗乙肝的又一个里程碑!”

              今天去医院和新的移植小组认识、聊天时,医生和药剂师估计FDA将很快通过!

              此外其它的药也有很看好的。

              另据星光医学网的报道:

              Adefovir Dipivoxil 10mg 的新药申请

              (2002-3-26 10:33:49  10)

              Dow Jones online news ----Gilead Sciences Inc(GILD)公司向FDA递交了其治疗慢性乙肝的药物adefovir dipivoxil 10mg的新药申请。   

              每日一次的adefovir能够有效安全地对抗病毒的变异, 可以成为市场上销售的其他同类药如,先灵葆雅的α干扰素,商品名为Intro A,以及葛兰素史克的3TC,商品名为Epivir的替代产品。

              然而, 一些支持adefovir 上市的人士却但心这种药物可能产生的肾脏毒性作用。 1999年, FDA专家顾问团拒绝同意高剂量的adefovir用于治疗HIV,因为它可能会产生很大的肾脏损伤, 为此,公司也停止了对adefovir治疗HIV的临床试验。 作为治疗慢性乙肝的药物, 低剂量的adefovir 好象不会对肾脏造成损伤,乙肝网, 但这种担忧仍然存在。

              新闻发布会上, Gilead 称, 新药申请中包括了adefovir治疗乙肝E抗原阳性病人, 乙肝E抗原阴性病人以及携带对拉米夫定有耐药性的乙肝病毒的慢性乙肝病人的肯定性的三期临床试验数据。

              Gilead公司原打算上半年在美国和欧洲完成adefovir的上市申请。但现在看来,估计FDA 的审查时限就需要6个月, 而欧洲的审查标准时限则为12个月。

              公司在上周二称, 会马上向欧盟提交 adefovir10mg的上市申请。

              (星光医药网 雪梅编译)

              ***********************************

              BW2564 MAR 21,2002 13:17 PACIFIC 16:17 EASTERN

              ( BW)(CA-GILEAD-SCIENCES)(GILD) Gilead Submits New Drug Application to U.S. FDA for Adefovir Dipivoxil 10 mg for the Treatment of Chronic Hepatitis B

              Business Editors/Health & Medical Writers

              FOSTER CITY, Calif.--(BUSINESS WIRE)--March 21, 2002--Gilead Sciences, Inc. (Nasdaq:GILD) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of adefovir dipivoxil 10 mg. Gilead is seeking an indication for the treatment of patients with chronic hepatitis B, including treatment-naive and treatment-experienced patients. The application is supported by data from Phase III studies in hepatitis B "e" antigen-positive patients, hepatitis B "e" antigen-negative patients and chronic hepatitis B patients with lamivudine-resistant HBV. Based on the unmet medical needs of patients with chronic hepatitis B, Gilead has submitted a request for a priority, or six-month, review of the adefovir dipivoxil NDA. The company will submit an application for marketing approval of adefovir dipivoxil 10 mg in Europe shortly.

              "Current therapeutic options are limited, and the need for safe, effective and durable treatments for patients with chronic hepatitis B is an urgent one," said John C. Martin, PhD, President and CEO, Gilead Sciences. "The achievement of this milestone marks an important advancement toward our goal of providing a potential new treatment to the many patients suffering from chronic hepatitis B. It also marks the second NDA submission for a novel Gilead antiviral in less than one year, underscoring our expertise and our leadership role in anti-infective therapies."

              About Adefovir Dipivoxil

              Adefovir dipivoxil belongs to a class of drugs called nucleotide analogues which are designed to work by blocking hepatitis B virus (HBV) DNA polymerase, an enzyme involved in the replication of the virus in the body.

              Data from two pivotal studies and a number of supportive studies of adefovir dipivoxil in a variety of chronic hepatitis B patient populations will be presented in April at the 37th Annual Meeting of the European Association for the Study of the Liver (EASL). Presentations include data from studies of hepatitis B "e" antigen-positive patients, precore mutant (hepatitis B "e" antigen-negative) patients, those with lamivudine-resistant HBV, patients post-liver transplantation and patients co-infected with HIV. Since 1999, Gilead has provided access to adefovir dipivoxil through Study 435 to approximately 400 chronic hepatitis B patients with lamivudine-resistant HBV who are wait listed for or have received a liver transplant. Adefovir dipivoxil is an investigational compound and has not yet been determined safe or efficacious in humans.

              Chronic Hepatitis B

            本文由网上采集发布,不代表我们立场,转载联系作者并注明出处:http://www.usagwa.com/a/ygxw/xinyaoyanzhi/704.html

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