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昙花一现:Olysio被FDA批准和Sovaldi联用用于一型丙肝的治疗

2014-11-10 佚名 美中药源

今天强生的丙肝药物Olysio(通用名Simeprevir)被FDA批准和Sovaldi联用用于一型丙肝的治疗。Olysio已经被批准和干扰素和利巴韦林联用用于一型丙肝的治疗。今天这个标签扩展是根据一个叫做COSMOS的开放标签二期临床。按理说标签扩展应该是好事,但Olysio虽然才上市不到一年实际上已是日落西山。 Olysio的经历可谓奇特,也反映了当前药品市场的复杂。Olysio是继默克

今天强生的丙肝药物Olysio(通用名Simeprevir)被FDA批准和Sovaldi联用用于一型丙肝的治疗。Olysio已经被批准和干扰素和利巴韦林联用用于一型丙肝的治疗。今天这个标签扩展是根据一个叫做COSMOS的开放标签二期临床。按理说标签扩展应该是好事,但Olysio虽然才上市不到一年实际上已是日落西山。

Olysio的经历可谓奇特,也反映了当前药品市场的复杂。Olysio是继默克的Victrelis (boceprevir,博赛泼维)和Vertex的Incivek (telaprevir,特拉泼维)之后第三个上市的NS3/4A蛋白酶抑制剂。Incivek曾经是制药史上最成功的药物上市之一,只用3个季度便超过10亿美元销售。然而天有不测风云,新一代丙肝药物如Sovaldi的出现使这个刚上市两年的明星药物去年被低价转让。Olysio作为第三个上市的me-too型药物虽然治疗时间短于Incivek和Victrelis,副作用也略小,但在sovaldi的威胁之下上市之初并不被看好。记得当时分析家预测的年销售是3500万美元。

然而Olysio上市第一年的表现却出乎包括强生管理层的意料,今年的销售可达20亿美元左右。这是为什么呢?这又得回到《顽主》那个经典镜头了。瘦骨嶙峋的马青:"我看谁TMD敢惹我?" 一壮汉:"我TMD敢惹你!" 马青:"那,,,,,,那,,,,,,谁TMD敢惹咱俩儿?"。既然打不过Sovaldi那就和它合作。强生的这个COSMOS实验可谓神来之笔,正是这个实验为他们今年挣了这20亿美元。这个实验结果早就公布了,根据这个结果权威的美国肝病研究协会很早就向医生推荐标签外使用Olysio和Sovaldi联用。Sovaldi成为历史上比Incivek强10倍(不是形容词,真是差不多10倍,Sovaldi前两个季度卖了60几亿)的产品上市,因此Olysio也跟着鸡犬升天,成为史上最成功的药品上市之一。据说iPhone 6也就和Incivek的吸金速度差不多,比sovaldi还有差距。

但是Olysio好日子马上就要到头了,因为吉利德科学自己的全口服复方Harvoni刚刚上市,12周只有94,000美元,较轻的病人只需用8周只要63,000美元。而Olysio标价66,000美元,加上Sovaldi的89,000美元价格上远远超过Harvoni,而且还得服用两片药而Harvoni是单片复方。所以除非Olysio大幅度降价,它借着Sovaldi狐假虎威的日子已经结束了。

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    2015-01-01 bugit
  3. [GetPortalCommentsPageByObjectIdResponse(id=2054757, encodeId=25c92054e5791, content=<a href='/topic/show?id=82491656057' target=_blank style='color:#2F92EE;'>#Sovaldi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16560, encryptionId=82491656057, topicName=Sovaldi)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83eqySEUYKeYDjXJMYMrtscBNkpAnLfQZgDcdkEratcJPqS7ARJOXqllZQhCSFicErlBFbIywuoiaP0LQ/132, createdBy=012d2500132, createdName=ms5880526374914242, createdTime=Tue Jul 14 23:06:00 CST 2015, time=2015-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839329, encodeId=cd6818393291c, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Thu Jan 01 12:06:00 CST 2015, time=2015-01-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=12903, encodeId=f30f129036b, content=丙肝新药很贵,需要到阿三那里去买。, beContent=null, objectType=article, channel=null, level=null, likeNumber=193, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTLlicehVzPC3BIG5MMT4o0D9CNdMrAdiaz1LvNJDqSoPjibHaiavyvkImlpzzneRgAwFEeCicwRjXhcHbw/132, createdBy=3f1689006, createdName=SSRIs, createdTime=Mon Dec 01 21:51:00 CST 2014, time=2014-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=12895, encodeId=519b12895eb, content=丙肝新药很贵,需要到阿三那里去买。, beContent=null, objectType=article, channel=null, level=null, likeNumber=124, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTLlicehVzPC3BIG5MMT4o0D9CNdMrAdiaz1LvNJDqSoPjibHaiavyvkImlpzzneRgAwFEeCicwRjXhcHbw/132, createdBy=3f1689006, createdName=SSRIs, createdTime=Mon Dec 01 21:49:00 CST 2014, time=2014-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1469390, encodeId=01d1146939010, content=<a href='/topic/show?id=9d6522e613' target=_blank style='color:#2F92EE;'>#ALD#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2276, encryptionId=9d6522e613, topicName=ALD)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=64f67025397, createdName=zhangjingnwpu, createdTime=Wed Nov 12 00:06:00 CST 2014, time=2014-11-12, status=1, ipAttribution=)]
    2014-12-01 SSRIs

    丙肝新药很贵,需要到阿三那里去买。

    0

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    2014-12-01 SSRIs

    丙肝新药很贵,需要到阿三那里去买。

    0

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    2014-11-12 zhangjingnwpu

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丙肝是一种由丙型肝炎病毒(HCV)感染引起的病毒性肝炎,能够形成病程几周的轻微肝脏疾病,严重的话则会导致肝癌。点击可放大上图由国际制药商协会联合会(InternationalFederation of Pharmaceutical Manufacturers &Associations)绘制而成,图中包含了丙肝是如何传播的,如何抑制丙肝,丙肝在全球的现状等信息。病毒性肝炎在世界各地都很流行

JAMA Int Med:阿片受体激动剂的维持疗法或可降低注射吸毒者感染丙肝的发生率

一项发表在国际杂志JAMA Internal Medicine上的研究报告中,来自波士顿大学医学院的研究人员通过研究表示,维持利用美沙酮或丁丙诺啡进行的阿片受体激动剂的治疗方法或许会降低年轻注射吸毒个体患丙肝的风险,其或许也是减少吸毒个体注射吸毒及传播丙肝的有效疗法。 利用注射毒品来吸毒是丙肝感染传播的主要途径,年轻的吸毒者是非常受关注的群体,因为其是引发丙肝感染传播的核心,对这些年轻吸毒者

Lancet:丙肝新型抗病毒药物疗法安全有效

根据发表在《柳叶刀》(The Lancet)杂志上的两项研究的结果,两种新型的抗病毒药物疗法为大多数的丙型肝炎病毒感染者,甚至是最难于治疗的患者,提供了更短期、更有效且副作用更小的治疗选择。 两项研究均将焦点放在了1型丙型肝炎上。1型丙型肝炎是在美国、欧洲、亚洲北部、澳大利亚和南美洲等地区最常见且最难治愈的丙肝基因型。 全球有大约1.5亿人有慢性丙型肝炎病毒(HCV)感染,丙肝是导致肝硬化

Sovaldi对日本人丙肝实现100%治愈率(GS-US-337-0113研究)

丙型肝炎ledipasvir/sofosbuvir固定剂量复方片(LDV/SOF,90mg/400mg,每日一次),商品名Sovaldi,在丙肝领域实际重大突破,主要成果发表在新英格兰期刊上。相关资讯见:Nature:7篇NEJM研究展示丙肝治疗的重大胜利 ,NEJM:六项丙肝临床研究同时发表,EASL 2014:SOF/LDV固定剂量组合对难治性丙肝患者安全有效  最近一项在日本的研究

吉利德丙肝地位撼动——百时美丙肝新药Daklinza获欧盟批准——鸡尾酒治愈率达100%

丙肝治疗领域,吉利德可谓独领风骚,其明星药物Sovaldi(sofosbuvir)在今年上半年的销售额突破58亿美元,为其带来了滚滚财源。然而,这一格局即将打破。 近日,百时美施贵宝(BMS)丙肝新药Daklinza(daclatasvir)获欧盟批准,联合其他药物,用于所有1、2、3、4基因型慢性丙型肝炎(HCV)成人感染者的治疗。Daklinza是一种强效的泛基因型NS5A复制复合体抑制剂,

肝福音——吉利德丙肝鸡尾酒LDV/SOF年底在欧美上市

导读:吉利德(Gilead)是丙型肝炎领域的领军人物,到目前为止,其明星药物Sovaldi(sofosbuvir)的销售额已突破70亿美元,而该公司正在开发的新一代丙肝鸡尾酒疗法LDV/SOF,近日在欧盟方面也传来了好消息,欧盟CHMP已建议批准LDV/SOF。美国方面,FDA预计也将在今年晚些时候批准LDV/SOF,商品名为Harvoni,该药预计将很快在欧美2大市场上市。Harvoni又将成为

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