• “蛟龙” 吸引世界目光(砥砺奋进的五年·重大工程巡礼) 2019-08-19
  • 李克强:扩大跨省异地就医直接结算范围 2019-08-11
  • 次仁卓玛一家的端午节 2019-08-11
  • 市人大常委会召开党组会议传达学习全国两会精神张轩主持并讲话 2019-08-09
  • 世界杯期间在家撸串的正确姿势-热门标签-华商网数码 2019-08-06
  • 兴业银行获第十二届人民企业社会责任奖年度企业奖 2019-08-02
  • 宝马中国创新日暨上海研发中心揭幕 专注于高新技术 2019-08-01
  • 解放军报评论员:担当起党和人民赋予的新时代使命任务 2019-08-01
  • 别人家的中年男子 听音识木一把琴能卖30万 2019-07-18
  • 《贪婪之秋》延期至2019年 E3新宣传片公开 2019-06-25
  • 《关于发展租赁型职工集体宿舍的意见(试行)》正式发布实施 2019-06-24
  • 网约车陷阱多 谨防四类风险 2019-06-19
  • 太原设禁鸣路段 设备在测试中 2019-06-19
  • 歌浴森专辑写真曝光 俏皮可爱萌态十足 2019-06-09
  • 破11个赛季不胜魔咒 山东客场击败广厦 2019-06-09
  • 来宝网Logo

    热门词:生物显微镜 水质分析仪 微波消解 荧光定量PCR 电化学工作站 生物安全柜

    现在位置时时彩网络平台>技术资料首页>行业动态>新品动态>FDA:批准罗氏集团成员Genentech公司Lucentis用于黄斑水肿

    天津中环线都有哪条路: FDA:批准罗氏集团成员Genentech公司Lucentis用于黄斑水肿

    Genentech2010年6月28日 10:22 点击:3997

    时时彩网络平台 www.qlgr.net
       美国食品药品监督管理局(FDA,U.S. Food and Drug Administration) 美国基因泰克公司(Genentech) 瑞士罗氏Roche
    据美国商业新闻社6月23日报道,罗氏集团成员Genentech公司宣布,经过优先审查,美国食品药品监督管理局(FDA)已经批准Lucentis雷珠单抗(ranibizumab )注射液用于治疗伴随视网膜静脉闭塞的黄斑水肿。在此之前该药物曾于2006年6月获得FDA批准用于治疗年龄相关性黄斑变性。

      专家表示,该药物将对饱受因网膜静脉闭塞黄斑水肿而视力渐失的患者提供了重要的新药,临床研究显示在用药一周后即有明显的视力维持效果。药物不良反应报告与之前的临床研究一致,并未有新的副作用报告,常见副作用有结膜出血,眼睛疼痛等,极少数的出现动脉血栓、脑中风、心肌梗死及急性冠脉综合症等严重药物不良反应事件。
     


    Tuesday, Jun 22, 2010
     

    FDA Approves Lucentis® (Ranibizumab Injection) for the Treatment of Macular Edema Following Retinal Vein Occlusion
     

    South San Francisco, Calif. --  June 22, 2010 --  Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Lucentis® (ranibizumab injection) for the treatment of macular edema following retinal vein occlusion (RVO). The FDA approved this new indication after a six-month Priority Review.

    "This approval provides an important new medicine for people experiencing the unexpected vision loss associated with macular edema following RVO," said Hal Barron, M.D., executive vice president, Global Development and chief medical officer. "In the Lucentis RVO clinical trials significantly more people treated with monthly Lucentis showed sustained vision improvement during the six-month study with an effect seen as early as seven days."

    About the Studies
    The BRAVO study assessed the safety and efficacy profile of Lucentis in a total of 397 patients with macular edema following branch-RVO. The CRUISE study assessed the safety and efficacy profile of Lucentis in a total of 392 patients with macular edema following central-RVO. During the first six-month period, participants in both trials received monthly injections of either 0.3 mg or 0.5 mg of Lucentis (n=527) or monthly sham injections (n=262). The primary endpoint of both studies was mean change from baseline in best-corrected visual acuity (BCVA) at six months compared with patients receiving sham injections. The studies were not designed to compare the two doses of Lucentis.

    In the BRAVO study, the percentage of patients in the Lucentis 0.5 mg study arm who gained 15 or more letters in BCVA from baseline at month six was 61 percent (compared with 29 percent in the sham injection arm). In the CRUISE study, the percentage of patients in the Lucentis 0.5 mg study arm who gained 15 or more letters in BCVA from baseline at month six was 48 percent (compared with 17 percent in the sham injection arm). At month six, patients in BRAVO who received 0.5 mg of Lucentis had a mean gain of 18.3 letters (compared to 7.3 letters in patients receiving sham injections). In the CRUISE study, at month six, patients who received 0.5 mg of Lucentis had a mean gain of 14.9 letters (compared to 0.8 letters for patients receiving sham injections).

    The adverse events reported in BRAVO and CRUISE were similar to previous studies, and no new safety events were observed. In BRAVO and CRUISE, the most common ocular adverse events that occurred in the Lucentis arms included conjunctival hemorrhage (48 percent) and eye pain (17 percent). Among non-ocular serious adverse events in the BRAVO study, one arterial thromboembolic event occurred in the sham injection group and two events occurred in the Lucentis 0.5 mg dose group: one cerebrovascular accident that resulted in death and one myocardial infarction. In CRUISE, non-ocular serious adverse events were uncommon and included one case of either myocardial infarction or acute coronary syndrome in each of the three groups. No cerebrovascular accidents or deaths occurred during the six-month treatment period in CRUISE.

    About RVO
    RVO affects more than 1 million people in the United States1 and is the second-most common cause of vision loss due to retinal vascular disease2, which can develop over a long period of time or occur suddenly. It occurs when the normal blood flow through a retinal vein becomes blocked, causing swelling (edema) and hemorrhages in the retina, which may result in vision loss. Sudden blurring or vision loss in all or part of one eye is common with RVO, although loss of vision can develop over a long period of time. RVO typically affects patients who are more than 50 years old, and the incidence increases with age. People with a history of high blood pressure, hypertension, diabetes and atherosclerosis are at an increased risk for developing RVO.

    There are two main types of RVO: branch-RVO, which affects an estimated 887,000 people, and central-RVO, which affects an estimated 265,000 people in the United States.1 Branch-RVO, which is three times more common than central-RVO3, occurs when one of the smaller veins emptying into the main vein of the eye becomes blocked. Usually, the blockage occurs at the site where an artery and a vein cross, and affects only a portion of the retina. Central-RVO, the less common form of RVO, occurs when the main vein of the eye (located at the optic nerve) becomes blocked.

    About Lucentis
    Lucentis is a vascular endothelial growth factor (VEGF) inhibitor which was first approved by the U.S. Food and Drug Administration (FDA) for the treatment of neovascular (wet) age-related macular degeneration (AMD) in 2006. In wet AMD clinical trials, Lucentis administered monthly demonstrated an improvement in vision of three lines or more on the study eye chart in up to 41 percent of patients at two years. Nearly all patients (90 percent) in those trials treated monthly with Lucentis maintained vision.

    Lucentis is designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. In RVO, angiogenesis and hyperpermeability can lead to macular edema, the swelling and thickening of the macula, which is the portion of the eye responsible for fine, detailed central vision.

    Lucentis is a prescription medication given by injection into the eye. Lucentis has been associated with detached retina and serious eye infection and should not be used in patients who have an infection in or around the eye. Increases in eye pressure have been seen within one hour of an injection. Although uncommon, conditions associated with eye- and non-eye-related blood clots (arterial thromboembolic events) may occur. Serious side effects include inflammation inside the eye and, rarely, effects related to the injection procedure such as cataract.

    The most common non-eye-related side effects are nose and throat infection, headache, and respiratory and urinary tract infections. The most common eye-related side effects are the feeling that something is in the eye, and increased tears. If a patient's eye becomes red, sensitive to light, painful, or has a change in vision, they should seek immediate care from their eye doctor.

    Please visit //www.lucentis.com for the Lucentis full prescribing information, and additional important safety information.

    Lucentis was discovered by Genentech and is being developed by Genentech and Novartis for diseases or disorders of the eye. Genentech (a member of the Roche Group) retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world.

    About Genentech Access Solutions
    Genentech is committed to people having access to our medicines. Genentech Access Solutions is a team of 400 Genentech employees who help those who need Genentech medicines. This team works with patients and doctors to resolve reimbursement and insurance issues and provides assistance to eligible patients in the United States who do not have insurance coverage or who cannot afford their out-of-pocket co-pay costs.

    Since its first medicine was approved in 1985, Genentech has donated approximately $1.5 billion in free Genentech medicines to the uninsured through the Genentech® Access to Care Foundation (GATCF) and other product donation programs. The household income limit to receive free medicine through GATCF is $100,000 per year. Since 2005, Genentech has also donated approximately $390 million to various independent, non-profit organizations that provide financial assistance to those who cannot access needed medical treatment due to co-pay costs.

    About Genentech
    Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit //www.gene.com.

     

    # # #
     

     

    1 Genentech data on file (Based on population-based studies/the Beaver Dam Eye Study 2000 and 2008 and the United States Census).

    2 Rehak J, Rehak M. Branch retinal vein occlusion: pathogenesis, visual prognosis, and treatment modalities. Curr Eye Res. 2008;33:111-131.

    3 Hamid S et al. Etiology and Management of Branch Retinal Vein Occlusion. World Applied Sciences Journal 6(1):94-99, 2009.

    (来源: Genentech )


    全年征稿 / 资讯合作

    联系邮箱:[email protected]

    版权与免责声明

    • 凡本网注明“来源:来宝网”的所有作品,版权均属于来宝网,转载请必须注明来宝网, 时时彩网络平台,违反者本网将追究相关法律责任。
    • 本网转载并注明自其它来源的作品,目的在于传递更多信息,并不代表本网赞同其观点或证实其内容的真实性,不承担此类作品侵权行为的直接责任及连带责任。其他媒体、网站或个人从本网转载时,必须保留本网注明的作品来源,并自负版权等法律责任。
    • 如涉及作品内容、版权等问题,请在作品发表之日起一周内与本网联系,否则视为放弃相关权利。


  • “蛟龙” 吸引世界目光(砥砺奋进的五年·重大工程巡礼) 2019-08-19
  • 李克强:扩大跨省异地就医直接结算范围 2019-08-11
  • 次仁卓玛一家的端午节 2019-08-11
  • 市人大常委会召开党组会议传达学习全国两会精神张轩主持并讲话 2019-08-09
  • 世界杯期间在家撸串的正确姿势-热门标签-华商网数码 2019-08-06
  • 兴业银行获第十二届人民企业社会责任奖年度企业奖 2019-08-02
  • 宝马中国创新日暨上海研发中心揭幕 专注于高新技术 2019-08-01
  • 解放军报评论员:担当起党和人民赋予的新时代使命任务 2019-08-01
  • 别人家的中年男子 听音识木一把琴能卖30万 2019-07-18
  • 《贪婪之秋》延期至2019年 E3新宣传片公开 2019-06-25
  • 《关于发展租赁型职工集体宿舍的意见(试行)》正式发布实施 2019-06-24
  • 网约车陷阱多 谨防四类风险 2019-06-19
  • 太原设禁鸣路段 设备在测试中 2019-06-19
  • 歌浴森专辑写真曝光 俏皮可爱萌态十足 2019-06-09
  • 破11个赛季不胜魔咒 山东客场击败广厦 2019-06-09
  • 黑龙江22选5历史开奖 内蒙古快3走势图跨度 三群骗局揭秘 快乐十分玩法介绍图解 幸运飞艇5码在线计划 足彩4场进球18158期对阵 北京快三玩法中奖规则 中国竞彩网模拟 nba全明星赛下载 中彩网开奖直播 体彩大乐透中奖号码 超级大乐透开奖规则 北京快3一定牛形态 快乐双彩复式计算 四肖中特期期准