不用本金就能赚钱的方法

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辉瑞创新药获FDA批准,填补罕见心脏病治疗空白

美通社2019年5月11日 8:38 点击:314

辉瑞公司5月6日宣布,美国食品药品监督管理局已批准 VYNDAQEL(R)(氯苯唑酸葡甲胺)和VYNDAMAX(TM)(氯苯唑酸)用于治疗成年人野生型或遗传型转甲状腺素蛋白淀粉样变心肌病,以降低心血管相关死亡率和住院率。

纽约2019年5月10日 /美通社/ -- 辉瑞公司(NYSE:PFE)近日宣布,美国食品药品监督管理局(FDA)已批准 VYNDAQEL®不用本金就能赚钱的方法(氯苯唑酸葡甲胺)和VYNDAMAX™(氯苯唑酸)用于治疗成年人野生型或遗传型转甲状腺素蛋白淀粉样变心肌病(ATTR-CM),以降低心血管相关死亡率和住院率。VYNDAQEL 和VYNDAMAX 是首个转甲状腺素蛋白稳定剂氯苯唑酸的两种口服制剂,也是第一个且目前唯一获得FDA批准治疗ATTR-CM的药物。

转甲状腺素蛋白淀粉样变心肌病是一种罕见的致死性疾病,其特点是错误折叠的蛋白质形成异常物质(淀粉样物质)沉积于心脏,表现为限制性心肌病和进行性心力衰竭。既往并没有获批治疗ATTR-CM的药物;可用的治疗方案仅仅包括对症治疗,在个别情况下进行心脏(或心脏与肝脏)移植。目前在美国大约有10万ATTR-CM患者,其中确诊的患者仅占1-2%。

 “VYNDAQEL HEVYNDAMAXDEHUOPI,SHIJIYUWOMENFAQIDECHUANGXINXINGGAISHANXINXUEGUANYUHOUDEYAOWUYANFAXIANGMU -- ATTR-ACTDESHIYANJIEGUO。NENGRANGZHEIXIEYAOWUZAOFUYUJIXUZHILIAODEATTR-CMHUANZHE,DUICIWOMENBEIGANZIHAO。”HUIRUIQUANQIUCHANPINYANFAHANJIANBINGSHIYEBUGAOJIFUZONGCAIJIANSHOUXIYANFAGUANBrenda CooperstoneBOSHIBIAOSHI,“VYNDAQEL HEVYNDAMAXKEYIJIANGDIZHEIZHONGYESHENGXINGHUOYICHUANXINGHANJIANBINGHUANZHEDEXINXUEGUANXIANGGUANSIWANGLVHEZHUYUANLV,RANGZHEIXIEHUANZHEYOUGENGDUODESHIJIANPEIBANTAMENDEZHIQIN。”

“辉瑞的目标是为患者带来改变其生活的突破创新。这次VYNDAQEL 和VYNDAMAX 的获批,体现了我们对ATTR-CM患者的这一承诺。”辉瑞罕见病事业部全球总裁Paul Levesque表示,“对于身患这种罕见的致死性疾病却无获批药物可供治疗的广大患者,这一里程碑无疑会给他们的生活带来突破性的改善不用本金就能赚钱的方法。我们仍将继续加强同学术组织的合作,提高人们对这种疾病的认知水平,并最终促进该疾病的发现和诊断。”

“ATTR-CM BUJINSHIZHISIXINGDE,ZHENDUANLVHAIFEICHANGDI,YIXIEHUANZHEKANLEHENDUOYISHENG,JINIANLIJIESHOULEHENDUOCIJIANCHA,BINGQINGQUEHAIZAIBUDUANEHUA。”DIANFENYANGBIANXINGYANJIULIANMENGCHUANGSHIRENJIANCEO Isabelle LousadaBIAOSHI,“DUIYUATTR-CM ZHEIZHONGHANJIANBING,XUYAOJIAQIANGJIAOYUHETIGAOJIBINGRENZHI。GAIYAODEHUOPIWEIHUANZHEDAILAILEZHONGDADEFUYIN;CIWAITONGYANGZHONGYAODESHI,WOMENZUOWEIYIGEZHENGTI,BIXUCHONGFENRENSHIDAOZAOQIZHENDUANDEZHONGYAOXING。”

ZHEICIFDADEPIZHUNSHIJIYUZHUANJIAZHUANGXIANSUDANBAIDIANFENYANGBIANXINJIBINGDEGUANJIANXINGSANQILINCHUANGSHIYAN(ATTR-ACT)DESHUJU,ZHEISHIDIYIGEQUANQIUFANWEIDESHUANGMANG、SUIJIHEANWEIJIDUIZHAODELINCHUANGYANJIU,ZHIZAIPINGJIAZHEIZHONGJIBINGDEYAOWUZHILIAOLIAOXIAO。ZAIATTR-ACTSHIYANZHONG,ZHILIAO30GEYUE,YUANWEIJIXIANGBI,VYNDAQELXIANZHUJIANGDIQUANYINSIWANGLVHEXINXUEGUANXIANGGUANZHUYUANLV(p=0.0006)。CIWAI,ZHUYAOZHONGDIANDEDANGEPINGJIAZHONGDIANJIEGUOZHENGMING,YUANWEIJIZUXIANGBI,VYNDAQELZUDEQUANYINSIWANGLVHEXINXUEGUANXIANGGUANZHUYUANLVFENBIEJIANGDILE30%(p=0.026)HE32%(p<0.0001)。ZAIZHEILIANGGEZHILIAOZUZHONG,DAYUE 80%DESIWANGBINGLIDOUSHIXINXUEGUANXIANGGUANDE。CONG6GEYUESUIFANGKAISHIHEHOULAICHIXU30GEYUEDESUIFANGZHONGFAXIAN,YUANWEIJIZUXIANGBI,VYNDAQELZUHAIZAIHUODONGNENGLIYUJIANKANGZHUANGTAIFANGMIANCHENGXIANMINGXIANERYIZHIDEZHILIAOXIAOGUO。YOUQIZHIDEGUANZHUDESHI,VYNDAQEL JIANSHAOLE6FENZHONGBUXINGCEYAN(p<0.0001)FENSHUDEXIAJIANG,BINGJIANSHAOLEKANSASICHENGXINJIBINGDIAOCHAWENJUANZONGDEFENSUOCEDINGDEJIANKANGZHUANGTAIDEXIAJIANG(p<0.0001)。ANQUANXINGPINGJIAXIANSHI,YUANWEIJIZUBIEXIANGBI,ZHEICIYANJIUZHONGHUANZHEDUIYUVYNDAQELDENAISHOUXINGLIANGHAO。VYNDAQELZHILIAODEHUANZHECHUXIANBULIANGSHIJIANDEPINLVHEANWEIJIZUXIANGDANG;YOUYUBULIANGSHIJIANERZHONGDUANZHILIAODEHUANZHE, VYNDAQELZUHEANWEIJIZUDEBILIXIANGDANG。

关于转甲状腺素蛋白淀粉样变心肌病(ATTR-CM)

不用本金就能赚钱的方法ZHUANJIAZHUANGXIANSUDANBAIDIANFENYANGBIANXINJIBING(ATTR-CM)SHIYIZHONGHANJIANDEZHISIXINGJIBING,YOUYIZHONGZHUANYUNDANBAI,ZHUANJIAZHUANGXIANSUDANBAIBUWENDINGYINQIDE。ZHUANJIAZHUANGXIANSUDANBAIYOU4GEXIANGTONGDEBUFEN(SIJUTI)ZUCHENG。DANGBUWENDINGDEZHUANJIAZHUANGXIANSUDANBAISIJUWUJIELI,JIUHUIDAOZHICUOWUZHEDIEDEDANBAIXINGCHENGDIANFENYANGXIANWEICHENJIYUXINZANG,CONGERSHIXINJIBIANDEJIANGYING,ZUIZHONGDAOZHIXINLISHUAIJIE。ATTR-CMYOULIANGZHONGYAXING:YIZHONGSHIYICHUANXING,YOUCHENGWEITUBIANXING,SHIYOUZHUANJIAZHUANGXIANSUDANBAIJIYINDETUBIANYINQIDE,HUANBINGNIANLINGJIAOZAO,WEI50ZHI60SUI;LINGYIZHONGWUTUBIAN,ERYUSHUAILAOYOUGUAN,CHENGWEIYESHENGXING,SHIGENGWEICHANGJIANDEYIZHONGLEIXING,TONGCHANGLEIJI60SUIYISHANGDENANXING。ATTR-CMDEHUANZHE,JINGCHANGSHIZAIZHENGZHUANGBIANDEHENYANZHONGZHIHOUCAIDEDAOZHENDUAN。YIDANQUEZHEN,GENJUYAXINGDEBUTONG,ATTR-CMHUANZHEDEZHONGWEIYUQISHOUMINGYUEWEI2ZHI3.5NIAN。

关于VYNDAQEL(tafamidis meglumine)VYNDAMAX(tafamidis)

VYNDAQEL(LVBENZUOSUANPUJIAAN,tafamidis meglumine)HEVYNDAMAX(LVBENZUOSUAN)DOUSHIKOUFUZHUANJIAZHUANGXIANSUDANBAIWENDINGJI,NENGGOUXUANZEXINGDIYUZHUANJIAZHUANGXIANSUDANBAIJIEHE,WENDINGZHUANJIAZHUANGXIANSUDANBAIDESIJUTI,JIANHUANDAOZHIATTR-CMDEDIANFENYANGWUZHIDEXINGCHENG。

VYNDAQELYU2012NIANZAIOUMENGHEMEIGUOHUODELEZHILIAOATTR-CMDEGUERYAORENDING,YU2018NIANZAIRIBENHUODEGUERYAORENDING。2017NIAN6YUEHE2018NIAN5YUE,MEIGUOFDAXIANHOUSHOUYULEVYNDAQELKUAISUSHENPINGZIGE,BINGRENDINGATTR-CMWEITUPOXINGLIAOFA。2018NIAN11YUE,MEIGUOFDAPIZHUNLEVYNDAQELXINYAOSHENQING(NDA)DEYOUXIANSHENPINGZIGE。

不用本金就能赚钱的方法2019NIAN3YUE,RIBENHOUSHENGLAODONGSHENGPIZHUNSHOUYUVYNDAQELYISAKIGAKE(LINGXIANXING,XIANQUXING)YAOWUCHENGHAO,YONGYUZHILIAOYESHENGXINGHEBIANYIXINGATTR-CMHUANZHE。GUANYUATTR-CMHUANZHESHIYONGVYNDAQELDEZHUCESHENQINGYIDIJIAOJIOUZHOUYAOPINGUANLIJU(EMA),MUQIANZHENGZAIJIESHOUSHENPING。

VYNDAQELYU2011NIANSHOUCIZAIOUMENGHUODEPIZHUNZHILIAOZHUANJIAZHUANGXIANSUDANBAIDIANFENYANGBIANDUOFASHENJINGBING(ATTR-PN),YONGYUZAOQIZHENGZHUANGXINGDUOFASHENJINGBINGDECHENGNIANHUANZHEYIYANHUANZHOUWEISHENJINGSUNSHANG。ATTR-PN SHIDIANFENYANGBIANXINGDEYIZHONGSHENJINGXITONGTUIXINGXINGJIBING,KEDAOZHIXIAZHIGANJUEQUESHI、TENGTONGHEWULI、YIJIZIZHUSHENJINGXITONGDESUNHAI。MUQIAN,TAYIZAI40GEGUOJIAHUOPIZHILIAO ATTR-PN,QIZHONGBAOKUORIBEN、YIXIEOUZHOUGUOJIA、BAXI、MOXIGE、AGENTING、YISELIE、ELUOSIHEHANGUO。VYNDAQEL HEVYNDAMAXZAIMEIGUOSHANGWEIHUOPIZHILIAOATTR-PN。

辉瑞罕见病事业部

不用本金就能赚钱的方法HANJIANBINGBAOKUOHENDUOYANZHONGDEJIBING,SHEJIQUANQIUJIBAIWANHUANZHE。HUIRUIZHILIYUYUNYONGWOMENDEZHISHIHEZHUANZHANGBANGZHUJIEJUEZHONGDAYIXUEXUQIU。WOMENDUIYUHANJIANBINGLINGYUDEGUANZHUJIYUZAIGAILINGYU20DUONIANDEJINGYAN、ZHUANZHUYUHANJIANBINGDEYANJIUBUMEN、YIJIZAIDUOGEZHILIAOLINGYU(BAOKUOXUEYEBINGXUE、SHENJINGBINGXUEHEYICHUANDAIXIEBING)DEYAOWU。

不用本金就能赚钱的方法HUIRUIHANJIANBINGSHIYEBUTONGGUOZONGHEYUNYONGXIANJINDEKEJIHEDUIJIBINGJILIDESHENRULEJIE,BINGRONGRULETONGGUANGDAXUESHUYANJIU/KEYANRENYUAN、HUANZHEHEQITAGONGSIKAIZHANCHUANGXINXINGZHANLVEHEZUOERHUODEDEZHENZHIZHUOJIAN,XINGCHENGGEZHONGBIANGEXINGDEZHILIAOTUJINGHEJIEJUEFANGAN。WOMENMEITIANDOUZAILIYONGGONGSIDEQUANQIUYINGXIANGLIKAIZHANCHUANGXIN,JIASUCHANPINYANFAJINCHENG,LIQIUZAORIWEIGUANGDAHUANZHEDAILAITUPOXINGDEYAOWUHEZHIYUDEXIWANG。

辉瑞公司:携手共创健康世界®

不用本金就能赚钱的方法ZAIHUIRUI,WOMENZHILIYUYUNYONGKEXUEYIJIWOMENDEQUANQIUZIYUANLAITIGONGNENGYANZHANGBINGMINGXIANGAISHANRENLEISHOUMINGDEZHILIAO。ZAIBAOJIANCHANPINDETANSUO、YANFAHESHENGCHANGUOCHENGZHONG,WOMENJUNJIANLILEZHILIANG、ANQUANHEJIAZHIBIAOZHUN。WOMENDEQUANQIUCHANPINXIANBAOKUOYAOPINHEYIMIAO,YIJIXUDUOSHIJIECHIMINGDEJIANKANGYAOWUCHANPIN。MEITIAN,FADAHEXINXINGSHICHANGDEHUIRUIYUANGONGDOUZHILIYUTUIJINJIANKANG,YIJINENGGOUYINGDUIWOMENZHEIGESHIDAIZUIWEIJISHOUDEJIBINGDEYUFANGHEZHILIAOFANGAN。HUIRUIHAIYUSHIJIEGEDIDEYILIAOWEISHENGZHUANYERENSHI、ZHENGFUHESHEQUHEZUO,ZHICHISHIJIEGEDIDERENMENNENGGOUHUODEGENGWEIKEKAOHEKECHENGFUDEYILIAOWEISHENGFUWU。ZHEIYUHUIRUIZUOWEIYIJIASHIJIEDECHUANGXINSHENGWUZHIYAOGONGSIDEZERENSHIYIZHIDE。170NIANLAI,HUIRUIYIZHINULIWEIRENMENTIGONGGENGHAO、GENGYOUZHIDEFUWU。RUXULEJIEGENGDUOXINXI,QINGDENGLU。

披露声明:本新闻稿中所含信息为截止201956日的信息。不管是由于新信息、未来事件还是进展,辉瑞一概不承担对前瞻性声明进行更新的义务。

本新闻稿中包含了关于辉瑞的罕见病药物VYNDAQEL(氯苯唑酸葡甲胺,tafamidis meglumine)和VYNDAMAX(氯苯唑酸,tafamidis)、以及在美国获批治疗ATTR-CM患者的前瞻性信息,包括其潜在的益处;这些信息包含重大的风险和不确定性,可能导致实际结果与此类陈述中明示或暗示的内容之间存在较大的差异。风险和不确定因素包括(除其他外):关于VYNDAQELVYNDAMAX能否取得商业成功的不确定性;研发过程中内在的不确定性,包括预期的临床终点能否达到、我们的临床试验开始和/或结束日期、注册提交日期是否得到满足,以及不利的新临床试验数据的可能性、和对现有临床数据的更多分析;这些临床试验数据面临药监部门不同解释和评估的风险;药监部门对于研究设计、以及我们的研究结果是否满意的风险;VYNDAQELVYNDAMAX在任何其它管辖范围内的新药或补充药物申请是否及何时可以被受理;关于VYNDAQELVYNDAMAX的此类申请经过未决期和归档备案期以后,能否及何时可获得欧洲药品管理局(EMA)的批准,在任何其它管辖范围内能否及何时可获得监管当局的批准,这取决于大量的因素,包括确定这种产品的益处是否超出了已知的风险、确定这种产品的有效性;而且,如果获得批准,还取决于VYNDAQELVYNDAMAX能否顺利实现商业化;药监部门就产品说明书、生产工艺、安全性与/或其它事项所做出的决定,这些决定可能影响VYNDAQELVYNDAMAX的可获取性或商业潜能;以及竞争性研发情况。

关于其他的风险与不确定因素,可参考截止20181231日辉瑞的财政年度报告(表格10-K)及其后续报告(表10-Q),均包含在标题为风险因素可能影响未来结果的前瞻性信息和因素部分、以及后续的报告(表8-K)之中,所有这些均在美国证券交易委员会(SEC)报备,并可通过查询。

消息来源:辉瑞公司


(来源: 美通社


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