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Shire在美国推出干眼病新药Xiidra,艾尔健丽眼达(Restasis)霸主地位不保

2016-09-02 佚名 生物谷

英国制药公司Shire近日宣布,在美国市场推出眼科药物Xiidra(lifitegrast滴眼液),该药于今年7月11日获得美国食品和药物管理局(FDA)批准,用于干眼病(DED)症状和体征的治疗,这是FDA批准的首个治疗干眼病的淋巴细胞功能相关抗原 1(LFA-1) 拮抗剂类新药,同时也是美国市场中唯一一种处方滴眼液,每日使用2次,每次相隔大约12小时。 Xiidra是过去13年里干眼病治疗领

英国制药公司Shire近日宣布,在美国市场推出眼科药物Xiidra(lifitegrast滴眼液),该药于今年7月11日获得美国食品和药物管理局(FDA)批准,用于干眼病(DED)症状和体征的治疗,这是FDA批准的首个治疗干眼病的淋巴细胞功能相关抗原 1(LFA-1) 拮抗剂类新药,同时也是美国市场中唯一一种处方滴眼液,每日使用2次,每次相隔大约12小时。

Xiidra是过去13年里干眼病治疗领域的首个新药,业界对其商业前景十分看好,预计年销售额将突破10亿美元,同时将成为艾尔健干眼病药物Restasis(品牌名:丽眼达,通用名:cyclosporine,环孢霉素)的强有力竞争对手。

目前,Restasis的药物标签描述称,该药能够增加眼睛产生泪液的能力,即该药实际上被定位为一种人工泪液的替代品。而Xiidra标签为干眼病症状和体征的治疗,标签范围更广。另外,尽管2种药物未开展头对头研究,但临床数据显示,Xiidra起效更快,在大约2周就能缓解病情,而Restasis需要6周或更长时间。而在价格方面,Xiidra售价与Restasis一致,大约为5000美元/年,可以预见的是,干眼病治疗市场的激烈对抗将一触即发。

根据艾尔建,Restasis在去年的销售额大约为13亿美元,是继该公司除皱产品保妥适(Botox)之后的第二大产品。一些分析师认为,尽管Xiidra将对Restasis带来严重威胁,但市场上2种产品的激烈对抗所伴随而来的干眼病治疗意识的提高,实际上同样也会使Restasis受益。

在过去的3年里,Shire公司已通过一系列收购建立起了眼科特许专营权,而Xiidra便是该公司在2013年出资1.6亿收购SARcode Bioscience获得。

值得一提的是,在欧洲市场,日本参天制药(Santen Pharma)开发的干眼病药物Ikervis(ciclosporin,环孢素)已于去年3月获欧盟批准,用于经人工泪液治疗为得到改善的干眼病成人患者严重角膜炎的治疗,成为欧洲上市的首个干眼病处方药。

关于Xiidra(lifitegrast)和干眼病

lifitegrast是一种新型的小分子整合素抑制剂,可结合整合素LFA-1(淋巴细胞功能相关抗原-1),阻断LFA-1与同源配体ICAM-1(胞间粘附分子-1)的相互作用。LFA-1是存在于白细胞表面的一种蛋白。在干眼病中,ICAM-1在角膜和结膜组织中过量表达。LFA-1/ICAM-1相互作用促进免疫突触的形成,导致T细胞激活并迁移至目标组织。

干眼病(dry eye disease,DED)又名角结膜干燥症(KCS),是指任何原因造成的泪液质或量异常或动力学异常,导致泪膜稳定性下降,并伴有眼部不适和(或)眼表组织病变特征的多种疾病的总称。它是目前最为常见的眼表疾病,主要治疗方法是使用人工泪液。

原始出处:

Shire launches dry eye drug Xiidra in US

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    2016-10-20 mhm289
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    2017-04-07 liuli5088
  5. [GetPortalCommentsPageByObjectIdResponse(id=2050556, encodeId=31932050556d3, content=<a href='/topic/show?id=95f8e042dd' target=_blank style='color:#2F92EE;'>#EST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7042, encryptionId=95f8e042dd, topicName=EST)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e9a6357, createdName=xiangyuzhou971, createdTime=Tue Feb 14 16:39:00 CST 2017, time=2017-02-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1794288, encodeId=953a1e9428897, content=<a href='/topic/show?id=fb7d16e489b' target=_blank style='color:#2F92EE;'>#STAS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16748, encryptionId=fb7d16e489b, topicName=STAS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=af60254, createdName=mhm289, createdTime=Thu Oct 20 19:39:00 CST 2016, time=2016-10-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793282, encodeId=35191e932827f, content=<a href='/topic/show?id=bd3015368b2' target=_blank style='color:#2F92EE;'>#Restasis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15368, encryptionId=bd3015368b2, topicName=Restasis)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=198d2500149, createdName=12498bd5m16暂无昵称, createdTime=Wed Oct 05 15:39:00 CST 2016, time=2016-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675160, encodeId=6eb216e516042, content=<a href='/topic/show?id=cb2116259ca' target=_blank style='color:#2F92EE;'>#Shire#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16259, encryptionId=cb2116259ca, topicName=Shire)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cdbc27169769, createdName=liuli5088, createdTime=Fri Apr 07 04:39:00 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1468766, encodeId=99a31468e66b8, content=<a href='/topic/show?id=e2d448e48ed' target=_blank style='color:#2F92EE;'>#干眼病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48748, encryptionId=e2d448e48ed, topicName=干眼病)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=34bd6933693, createdName=zhaozuguo, createdTime=Sun Sep 04 08:39:00 CST 2016, time=2016-09-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1527309, encodeId=abac152e30971, content=<a href='/topic/show?id=533248e474a' target=_blank style='color:#2F92EE;'>#干眼#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48747, encryptionId=533248e474a, topicName=干眼)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=11b211837688, createdName=nian.wang1986, createdTime=Sun Sep 04 08:39:00 CST 2016, time=2016-09-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1540489, encodeId=8101154048953, content=<a href='/topic/show?id=fbbce2786cc' target=_blank style='color:#2F92EE;'>#眼病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72786, encryptionId=fbbce2786cc, topicName=眼病)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b85c13256921, createdName=pps20023, createdTime=Sun Sep 04 08:39:00 CST 2016, time=2016-09-04, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=2050556, encodeId=31932050556d3, content=<a href='/topic/show?id=95f8e042dd' target=_blank style='color:#2F92EE;'>#EST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7042, encryptionId=95f8e042dd, topicName=EST)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e9a6357, createdName=xiangyuzhou971, createdTime=Tue Feb 14 16:39:00 CST 2017, time=2017-02-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1794288, encodeId=953a1e9428897, content=<a href='/topic/show?id=fb7d16e489b' target=_blank style='color:#2F92EE;'>#STAS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16748, encryptionId=fb7d16e489b, topicName=STAS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=af60254, createdName=mhm289, createdTime=Thu Oct 20 19:39:00 CST 2016, time=2016-10-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793282, encodeId=35191e932827f, content=<a href='/topic/show?id=bd3015368b2' target=_blank style='color:#2F92EE;'>#Restasis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15368, encryptionId=bd3015368b2, topicName=Restasis)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=198d2500149, createdName=12498bd5m16暂无昵称, createdTime=Wed Oct 05 15:39:00 CST 2016, time=2016-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675160, encodeId=6eb216e516042, content=<a href='/topic/show?id=cb2116259ca' target=_blank style='color:#2F92EE;'>#Shire#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16259, encryptionId=cb2116259ca, topicName=Shire)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cdbc27169769, createdName=liuli5088, createdTime=Fri Apr 07 04:39:00 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1468766, encodeId=99a31468e66b8, content=<a href='/topic/show?id=e2d448e48ed' target=_blank style='color:#2F92EE;'>#干眼病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48748, encryptionId=e2d448e48ed, topicName=干眼病)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=34bd6933693, createdName=zhaozuguo, createdTime=Sun Sep 04 08:39:00 CST 2016, time=2016-09-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1527309, encodeId=abac152e30971, content=<a href='/topic/show?id=533248e474a' target=_blank style='color:#2F92EE;'>#干眼#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48747, encryptionId=533248e474a, topicName=干眼)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=11b211837688, createdName=nian.wang1986, createdTime=Sun Sep 04 08:39:00 CST 2016, time=2016-09-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1540489, encodeId=8101154048953, content=<a href='/topic/show?id=fbbce2786cc' target=_blank style='color:#2F92EE;'>#眼病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72786, encryptionId=fbbce2786cc, topicName=眼病)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b85c13256921, createdName=pps20023, createdTime=Sun Sep 04 08:39:00 CST 2016, time=2016-09-04, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=2050556, encodeId=31932050556d3, content=<a href='/topic/show?id=95f8e042dd' target=_blank style='color:#2F92EE;'>#EST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7042, encryptionId=95f8e042dd, topicName=EST)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e9a6357, createdName=xiangyuzhou971, createdTime=Tue Feb 14 16:39:00 CST 2017, time=2017-02-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1794288, encodeId=953a1e9428897, content=<a href='/topic/show?id=fb7d16e489b' target=_blank style='color:#2F92EE;'>#STAS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16748, encryptionId=fb7d16e489b, topicName=STAS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=af60254, createdName=mhm289, createdTime=Thu Oct 20 19:39:00 CST 2016, time=2016-10-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793282, encodeId=35191e932827f, content=<a href='/topic/show?id=bd3015368b2' target=_blank style='color:#2F92EE;'>#Restasis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15368, encryptionId=bd3015368b2, topicName=Restasis)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=198d2500149, createdName=12498bd5m16暂无昵称, createdTime=Wed Oct 05 15:39:00 CST 2016, time=2016-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675160, encodeId=6eb216e516042, content=<a href='/topic/show?id=cb2116259ca' target=_blank style='color:#2F92EE;'>#Shire#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16259, encryptionId=cb2116259ca, topicName=Shire)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cdbc27169769, createdName=liuli5088, createdTime=Fri Apr 07 04:39:00 CST 2017, time=2017-04-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1468766, encodeId=99a31468e66b8, content=<a href='/topic/show?id=e2d448e48ed' target=_blank style='color:#2F92EE;'>#干眼病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48748, encryptionId=e2d448e48ed, topicName=干眼病)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=34bd6933693, createdName=zhaozuguo, createdTime=Sun Sep 04 08:39:00 CST 2016, time=2016-09-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1527309, encodeId=abac152e30971, content=<a href='/topic/show?id=533248e474a' target=_blank style='color:#2F92EE;'>#干眼#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48747, encryptionId=533248e474a, topicName=干眼)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=11b211837688, createdName=nian.wang1986, createdTime=Sun Sep 04 08:39:00 CST 2016, time=2016-09-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1540489, encodeId=8101154048953, content=<a href='/topic/show?id=fbbce2786cc' target=_blank style='color:#2F92EE;'>#眼病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72786, encryptionId=fbbce2786cc, topicName=眼病)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b85c13256921, createdName=pps20023, createdTime=Sun Sep 04 08:39:00 CST 2016, time=2016-09-04, status=1, ipAttribution=)]
    2016-09-04 pps20023

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