FDA为Alnylam的RNAi疗法Lumasiran授予优先审查,用于治疗1型原发性高草酸尿症

2020-06-03 MedSci原创 MedSci原创

Lumasiran是靶向羟基酸氧化酶1(HAO1)、可按季度皮下给药的的RNAi治疗药物。

全球领先的RNAi疗法公司Alnylam Pharmaceuticals宣布,美国食品药品管理局(FDA)已接受该公司lumasiran的新药申请(NDA),用于治疗1型原发性高草酸尿症(PH1)。FDA还为lumasiran授予了优先审查。

Lumasiran是一种研究性、皮下给药的靶向羟基酸氧化酶1(HAO1)的RNAi治疗药物,正在开发用于治疗PH1。HAO1编码乙醇酸氧化酶(GO)。因此通过沉默HAO1并耗尽GO酶,lumasiran可以抑制草酸盐的产生,草酸盐是直接影响PH1病理生理的代谢产物。

PH1是一种极少见的疾病,其中草酸盐的过量产生导致草酸钙晶体在肾脏和泌尿道中的沉积,并可能导致疼痛和复发性肾结石的形成和肾钙化。尽管少数患者对维生素B6疗法有完全反应,但尚无批准的PH1药物疗法。

Lumasiran是利用Alnylam的增强稳定化学(ESC)-GalNAc-缀合物技术,可按季度进行皮下维持给药,并具有更高的耐用性和广泛的治疗指数。Lumasiran已获得美国和欧盟的孤儿药称号,美国食品和药物管理局(FDA)的突破性疗法称号和小儿罕见病称号,以及欧洲药品管理局(EMA)的优先药品(PRIME)称号。

原始出处:

https://www.firstwordpharma.com/node/1727177?tsid=4

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    2021-05-10 lxg951
  2. [GetPortalCommentsPageByObjectIdResponse(id=2057678, encodeId=2452205e678cf, content=<a href='/topic/show?id=c02b106e29a' target=_blank style='color:#2F92EE;'>#LAM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10672, encryptionId=c02b106e29a, topicName=LAM)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04ce158, createdName=lxg951, createdTime=Mon May 10 06:17:59 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=901117, encodeId=974490111e67, content=已经拜读学习,点赞点赞了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7s7ZCKOmmbBTD6nE7gcd5OZpvyGEzkxBP3S275k5ZJVrsPkotZhBglRHM9rKvcj1OgkssqhcnoPw8zIaMZTF8c/0, createdBy=4c441942088, createdName=ylzr123, createdTime=Sun Nov 22 09:00:13 CST 2020, time=2020-11-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1704842, encodeId=63f71e048424c, content=<a href='/topic/show?id=be56234245' target=_blank style='color:#2F92EE;'>#Alnylam#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2342, encryptionId=be56234245, topicName=Alnylam)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfb930846673, createdName=zz12341244, createdTime=Sun Oct 04 01:17:59 CST 2020, time=2020-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=809299, encodeId=201080929986, content=好文,受益匪浅!点赞了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7s7ZCKOmmbBTD6nE7gcd5OZpvyGEzkxBP3S275k5ZJVrsPkotZhBglRHM9rKvcj1OgkssqhcnoPw8zIaMZTF8c/0, createdBy=4c441942088, createdName=ylzr123, createdTime=Sun Aug 16 08:49:06 CST 2020, time=2020-08-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1751680, encodeId=2b501e51680cc, content=<a href='/topic/show?id=2c2c1553e56' target=_blank style='color:#2F92EE;'>#RNAi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15537, encryptionId=2c2c1553e56, topicName=RNAi)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d9d436366397, createdName=yinxm8315, createdTime=Fri May 07 08:17:59 CST 2021, time=2021-05-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1846895, encodeId=178e184689514, content=<a href='/topic/show?id=d3a33e0306d' target=_blank style='color:#2F92EE;'>#原发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37030, encryptionId=d3a33e0306d, topicName=原发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8e4c53, createdName=jiyangfei, createdTime=Sun Jan 03 19:17:59 CST 2021, time=2021-01-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400161, encodeId=7383140016181, content=<a href='/topic/show?id=0b0e25e2913' target=_blank style='color:#2F92EE;'>#优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25729, encryptionId=0b0e25e2913, topicName=优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=80942248041, createdName=yxch37, createdTime=Fri May 29 00:17:59 CST 2020, time=2020-05-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1536868, encodeId=ac68153686879, content=<a href='/topic/show?id=7cad1554076' target=_blank style='color:#2F92EE;'>#RNAi疗法Lumasiran#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15540, encryptionId=7cad1554076, topicName=RNAi疗法Lumasiran)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fe1712732896, createdName=fzwish20004, createdTime=Fri May 29 00:17:59 CST 2020, time=2020-05-29, status=1, ipAttribution=)]
    2020-11-22 ylzr123

    已经拜读学习,点赞点赞了!

    0

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    2020-08-16 ylzr123

    好文,受益匪浅!点赞了。

    0

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    2021-05-07 yinxm8315
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