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9价HPV疫苗获优先审评 有望扩大适用年龄

2018-06-20 佚名 药明康德

默沙东(MSD)今天宣布,FDA已接受该公司的GARDASIL?9疫苗扩大适应症的申请(sBLA)。Gardasil 9是一款九价人乳头状瘤病毒(HPV)疫苗,用来预防9类HPV引起的癌症和疾病。此次申请将Gardasil 9疫苗使用的年龄范围从已批准的9到26岁,扩展到27至45岁的女性和男性。FDA已经授予该sBLA优先审评资格,有望在2018年10月6日之前给出答复。在美国,大多数性活跃的男

默沙东(MSD)今天宣布,FDA已接受该公司的GARDASIL?9疫苗扩大适应症的申请(sBLA)。

Gardasil 9是一款九价人乳头状瘤病毒(HPV)疫苗,用来预防9类HPV引起的癌症和疾病。此次申请将Gardasil 9疫苗使用的年龄范围从已批准的9到26岁,扩展到27至45岁的女性和男性。FDA已经授予该sBLA优先审评资格,有望在2018年10月6日之前给出答复。

在美国,大多数性活跃的男性和女性会在其一生中感染HPV。据美国疾病控制与预防中心(CDC)统计,美国每年约有1400万新增HPV生殖器感染,其中一半发生在15至24岁的人群中。虽然对大多数人群来说,HPV可在感染数月自然清除,但倘若无法进行清除,就可能导致某些癌症和其它疾病,而目前尚无法预测HPV能否自然清除。美国每年约有13200名妇女被诊断为宫颈癌,而HPV感染是几乎所有宫颈癌的起因。HPV也导致女性约70-75%的阴道癌和约30%的外阴癌。同时HPV导致男性和女性约85-90%的肛门癌和90%的生殖器疣。过去观点认为HPV疫苗接种最好是在有第一次实质性性接触之前,美国CDC推荐初次接种年龄为11、12岁。2012年韩国的研究显示,HPV感染或由此引发的宫颈病变治愈后,进行HPV疫苗接种可以减少疾病的复发率。

▲Gardasil 9可针对9类主要的HPV病毒(图片来源:Gardasil 9官网)

HPV疫苗是全球第一个用于预防肿瘤,并把癌症作为适应症列入说明书的疫苗。这种疫苗由HPV衣壳蛋白组成的病毒样颗粒经高度纯化混合制成的,注射后可激发人体自身免疫力。疫苗本身是蛋白,没有病毒的功能,也不会造成病毒感染。Gardasil 9(HPV类型6,11,16,18,31,33,45,52和58)是款九价疫苗。Gardasil 9中的后七种HPV类型导致约90%的宫颈癌,约80%的高度宫颈病变,90%HPV相关的外阴癌,85%HPV相关的阴道癌,和90%HPV相关的肛门癌。余下的两种HPV类型6和11,则导致约90%的生殖器疣。此外,约50%的低度宫颈病变是由疫苗中包含的9种HPV类型引起的。

默沙东研究试验室临床研究总监Alain Luxembourg博士说:“27至45岁的女性和男性仍面临着高风险感染HPV,可导致宫颈癌和其它与HPV相关的癌症和疾病。默沙东期待着与FDA配合,审查通过Gardasil 9这次扩大年龄适应症的申请。如果获批,更广阔年龄范围的人群将能接受到该疫苗提供的预防和保护作用。”

我们期待着此次Gardasil 9扩大年龄适用范围的sBLA早日获批,帮助不同年龄范围的人群预防HPV引起的癌症和其他疾病!

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    2018-06-21 kafei

    了解一下谢谢

    0

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    2018-06-20 明月清辉

    谢谢分享.学习了

    0

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