药械

订阅

MedSci主页 / 所有栏目 / 药械

FDA批准Ofev对于特发性肺纤维化的治疗

2014-10-28 杨辉 译 医学论坛网

Ofev特发性肺纤维化FDA
关注

美国食品和药物管理局于10月15日批准了Ofev(nintedanib)对于特发性肺纤维化(IPE)的治疗。 特发性肺纤维化是一种肺部随时间逐步瘢痕化的疾病。这将导致患有IPF的患者出现呼吸短促、咳嗽的症状，并且难以参加日常体育活动。现有的IPF疗法包括氧气疗法、肺康复和肺移植。 “今天对于Ofev的批准增加了患有特发性肺纤维化这种严重慢性疾病的患者的可用治疗选择”，FDA药物评价

美国食品和药物管理局于10月15日批准了Ofev(nintedanib)对于特发性肺纤维化(IPE)的治疗。

特发性肺纤维化是一种肺部随时间逐步瘢痕化的疾病。这将导致患有IPF的患者出现呼吸短促、咳嗽的症状，并且难以参加日常体育活动。现有的IPF疗法包括氧气疗法、肺康复和肺移植。

“今天对于Ofev的批准增加了患有特发性肺纤维化这种严重慢性疾病的患者的可用治疗选择”，FDA药物评价与研究中心药品评价办公室II的副主任MaryH.Parks医学博士说：“为医疗卫生专业人员和患者提供更多的治疗选择能帮助确保基于患者的需求做出合适的照护决定。”

FDA授予Ofev快速通道、孤儿药和突破性疗法认证。Ofev在该产品的处方药申报者付费目标日期的2015年1月2日前通过批准，该日期为FDA计划完成对于药品申请审批的日期。

Ofev为一种阻断多路径的激酶抑制剂，所述路径可能包括肺组织的瘢痕化。其安全性与有效性在包含1231名患有IPF的患者的三个临床试验中得到确定。服用Ofev的患者与服用安慰剂的患者相比，用力肺活量(即尽最大力深呼吸后用力从肺中呼出的空气的量)衰退的现象得到显著的减少。

不建议患有中度至重度肝脏疾病的患者服用Ofev。Ofev可能导致未出生婴儿的天生缺陷或死亡。女性患者在服用Ofev期间不应怀孕。能够怀孕的女性患者应当在服用Ofev期间以及服用最后一剂Ofev后至少三个月内采取足够的避孕措施。

Ofev最常见的不良反应为腹泻、恶心、腹痛、呕吐、肝酶升高、食欲减退、头痛、体重降低和高血压。

FDA今日还批准了Esbriet(pirfenidone)对于IPF的治疗。

Ofev由美国康涅狄格州里奇菲尔德的BoehringerIngelheim制药有限公司(BoehringerIngelheimPharmaceuticals,Inc.,Ridgefield,Connecticut)分销。

资料来源：EMA网站


版权声明：
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料，版权均属于梅斯医学所有。非经授权，任何媒体、网站或个人不得转载，授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章，或“梅斯号”自媒体发布的文章，仅系出于传递更多信息之目的，本站仅负责审核内容合规，其内容不代表本站立场，本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系，我们将立即进行删除处理。
在此留言
评论区 (5)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1894554, encodeId=c034189455491, content=<a href='/topic/show?id=e45b6e859f3' target=_blank style='color:#2F92EE;'>#特发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=67859, encryptionId=e45b6e859f3, topicName=特发性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=xinxin088, createdTime=Thu Apr 16 07:11:00 CST 2015, time=2015-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2058451, encodeId=812e205845150, content=<a href='/topic/show?id=1b69e363bb' target=_blank style='color:#2F92EE;'>#FEV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7363, encryptionId=1b69e363bb, topicName=FEV)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=医者仁心, createdTime=Mon Feb 23 09:11:00 CST 2015, time=2015-02-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839324, encodeId=3d61183932481, 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=20, 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=Tue Nov 04 02:11:00 CST 2014, time=2014-11-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558445, encodeId=d41815584459c, content=<a href='/topic/show?id=ff111326666' target=_blank style='color:#2F92EE;'>#Ofev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13266, encryptionId=ff111326666, topicName=Ofev)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2c4f14981834, createdName=respect, createdTime=Thu Oct 30 04:11:00 CST 2014, time=2014-10-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564454, encodeId=b95a1564454f2, content=<a href='/topic/show?id=ff111326666' target=_blank style='color:#2F92EE;'>#Ofev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13266, encryptionId=ff111326666, topicName=Ofev)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2c4f14981834, createdName=respect, createdTime=Thu Oct 30 04:11:00 CST 2014, time=2014-10-30, status=1, ipAttribution=)]
    2015-04-16 xinxin088

    #特发性#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1894554, encodeId=c034189455491, content=<a href='/topic/show?id=e45b6e859f3' target=_blank style='color:#2F92EE;'>#特发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=67859, encryptionId=e45b6e859f3, topicName=特发性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=xinxin088, createdTime=Thu Apr 16 07:11:00 CST 2015, time=2015-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2058451, encodeId=812e205845150, content=<a href='/topic/show?id=1b69e363bb' target=_blank style='color:#2F92EE;'>#FEV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7363, encryptionId=1b69e363bb, topicName=FEV)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=医者仁心, createdTime=Mon Feb 23 09:11:00 CST 2015, time=2015-02-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839324, encodeId=3d61183932481, 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=20, 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=Tue Nov 04 02:11:00 CST 2014, time=2014-11-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558445, encodeId=d41815584459c, content=<a href='/topic/show?id=ff111326666' target=_blank style='color:#2F92EE;'>#Ofev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13266, encryptionId=ff111326666, topicName=Ofev)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2c4f14981834, createdName=respect, createdTime=Thu Oct 30 04:11:00 CST 2014, time=2014-10-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564454, encodeId=b95a1564454f2, content=<a href='/topic/show?id=ff111326666' target=_blank style='color:#2F92EE;'>#Ofev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13266, encryptionId=ff111326666, topicName=Ofev)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2c4f14981834, createdName=respect, createdTime=Thu Oct 30 04:11:00 CST 2014, time=2014-10-30, status=1, ipAttribution=)]
    2015-02-23 医者仁心

    #FEV#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1894554, encodeId=c034189455491, content=<a href='/topic/show?id=e45b6e859f3' target=_blank style='color:#2F92EE;'>#特发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=67859, encryptionId=e45b6e859f3, topicName=特发性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=xinxin088, createdTime=Thu Apr 16 07:11:00 CST 2015, time=2015-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2058451, encodeId=812e205845150, content=<a href='/topic/show?id=1b69e363bb' target=_blank style='color:#2F92EE;'>#FEV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7363, encryptionId=1b69e363bb, topicName=FEV)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=医者仁心, createdTime=Mon Feb 23 09:11:00 CST 2015, time=2015-02-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839324, encodeId=3d61183932481, 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=20, 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=Tue Nov 04 02:11:00 CST 2014, time=2014-11-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558445, encodeId=d41815584459c, content=<a href='/topic/show?id=ff111326666' target=_blank style='color:#2F92EE;'>#Ofev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13266, encryptionId=ff111326666, topicName=Ofev)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2c4f14981834, createdName=respect, createdTime=Thu Oct 30 04:11:00 CST 2014, time=2014-10-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564454, encodeId=b95a1564454f2, content=<a href='/topic/show?id=ff111326666' target=_blank style='color:#2F92EE;'>#Ofev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13266, encryptionId=ff111326666, topicName=Ofev)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2c4f14981834, createdName=respect, createdTime=Thu Oct 30 04:11:00 CST 2014, time=2014-10-30, status=1, ipAttribution=)]
    2014-11-04 bugit

    #FDA批准#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1894554, encodeId=c034189455491, content=<a href='/topic/show?id=e45b6e859f3' target=_blank style='color:#2F92EE;'>#特发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=67859, encryptionId=e45b6e859f3, topicName=特发性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=xinxin088, createdTime=Thu Apr 16 07:11:00 CST 2015, time=2015-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2058451, encodeId=812e205845150, content=<a href='/topic/show?id=1b69e363bb' target=_blank style='color:#2F92EE;'>#FEV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7363, encryptionId=1b69e363bb, topicName=FEV)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=医者仁心, createdTime=Mon Feb 23 09:11:00 CST 2015, time=2015-02-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839324, encodeId=3d61183932481, 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=20, 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=Tue Nov 04 02:11:00 CST 2014, time=2014-11-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558445, encodeId=d41815584459c, content=<a href='/topic/show?id=ff111326666' target=_blank style='color:#2F92EE;'>#Ofev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13266, encryptionId=ff111326666, topicName=Ofev)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2c4f14981834, createdName=respect, createdTime=Thu Oct 30 04:11:00 CST 2014, time=2014-10-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564454, encodeId=b95a1564454f2, content=<a href='/topic/show?id=ff111326666' target=_blank style='color:#2F92EE;'>#Ofev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13266, encryptionId=ff111326666, topicName=Ofev)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2c4f14981834, createdName=respect, createdTime=Thu Oct 30 04:11:00 CST 2014, time=2014-10-30, status=1, ipAttribution=)]
    2014-10-30 respect

    #Ofev#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1894554, encodeId=c034189455491, content=<a href='/topic/show?id=e45b6e859f3' target=_blank style='color:#2F92EE;'>#特发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=67859, encryptionId=e45b6e859f3, topicName=特发性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=xinxin088, createdTime=Thu Apr 16 07:11:00 CST 2015, time=2015-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2058451, encodeId=812e205845150, content=<a href='/topic/show?id=1b69e363bb' target=_blank style='color:#2F92EE;'>#FEV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7363, encryptionId=1b69e363bb, topicName=FEV)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=医者仁心, createdTime=Mon Feb 23 09:11:00 CST 2015, time=2015-02-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839324, encodeId=3d61183932481, 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=20, 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=Tue Nov 04 02:11:00 CST 2014, time=2014-11-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558445, encodeId=d41815584459c, content=<a href='/topic/show?id=ff111326666' target=_blank style='color:#2F92EE;'>#Ofev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13266, encryptionId=ff111326666, topicName=Ofev)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2c4f14981834, createdName=respect, createdTime=Thu Oct 30 04:11:00 CST 2014, time=2014-10-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564454, encodeId=b95a1564454f2, content=<a href='/topic/show?id=ff111326666' target=_blank style='color:#2F92EE;'>#Ofev#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13266, encryptionId=ff111326666, topicName=Ofev)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2c4f14981834, createdName=respect, createdTime=Thu Oct 30 04:11:00 CST 2014, time=2014-10-30, status=1, ipAttribution=)]
    2014-10-30 respect

    #Ofev#

    0