FDA授予MC-1治疗磷酸吡哆醇(胺)氧化酶(PNPO)缺乏症的“孤儿药称号”

2021-01-08 Allan MedSci原创

心血管药品公司Medicure今天宣布,美国食品药品监督管理局(FDA)已经授予MC-1治疗磷酸吡哆醇(胺)氧化酶(PNPO)缺乏症的“孤儿药称号”。

血管药品公司Medicure今天宣布,美国食品药品监督管理局(FDA)已经授予MC-1治疗磷酸吡哆醇(胺)氧化酶(PNPO)缺乏症的“孤儿药称号”。

磷酸吡哆醇(胺)氧化酶(PNPO)缺乏症是一种常染色体隐性遗传病,特征为新生儿期即出现严重的癫痫性脑病,对各种抗癫痫药无效,吡哆醇治疗无效或仅有部分疗效。多可被磷酸吡哆醛(PLP)单药控制,PLP撤药后癫痫发作反复。大多数患者的PNPO基因都有突变。Medicure将进行III期临床试验,旨在评估MC-1治疗PNPO缺乏症的有效性和安全性。

此外,欧洲药品管理局(EMA)已授予MC-1罕见儿科疾病称号,用于治疗与PNPO缺乏症有关的癫痫发作。

Medicure首席执行官兼董事会主席Albert D. Friesen博士说:“MC-1有望成为FDA批准的首个针对PNPO缺乏症患者的疗法。从FDA获得孤儿药称号和罕见儿科疾病称号是MC-1的里程碑”。

 

原始出处:

https://www.firstwordpharma.com/node/1789611?tsid=4

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  1. [GetPortalCommentsPageByObjectIdResponse(id=2176053, encodeId=4b2521e605311, content=我家孩子也是这个病,两岁多了,有病友有群的吗?juan2356741791, beContent=null, objectType=article, channel=null, level=null, likeNumber=13, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a3648276345, createdName=ms8000001901220492, createdTime=Wed Dec 20 09:55:52 CST 2023, time=2023-12-20, status=1, ipAttribution=湖南省), GetPortalCommentsPageByObjectIdResponse(id=2122568, encodeId=5046212256802, content=我家孩子就是这个病,怎么才能买到这个药, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6e1c8524523, createdName=ms3000000756023345, createdTime=Wed Mar 29 22:11:17 CST 2023, time=2023-03-29, status=1, ipAttribution=湖北省), GetPortalCommentsPageByObjectIdResponse(id=1238713, encodeId=68871238e13e6, content=请问这个药哪里可以买到?, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=94958276361, createdName=ms6000002046775579, createdTime=Mon Aug 15 01:01:20 CST 2022, time=2022-08-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675248, encodeId=ce5816e524817, content=<a href='/topic/show?id=b9f214438ea' target=_blank style='color:#2F92EE;'>#PNP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14438, encryptionId=b9f214438ea, topicName=PNP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b29b27191603, createdName=cy0333, createdTime=Tue Mar 16 11:07:27 CST 2021, time=2021-03-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1365258, encodeId=d48813652589c, content=<a href='/topic/show?id=dfa045434e1' target=_blank style='color:#2F92EE;'>#孤儿药称号#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45434, encryptionId=dfa045434e1, topicName=孤儿药称号)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cd0d217, createdName=huiwelcome, createdTime=Sun Jan 10 11:07:27 CST 2021, time=2021-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=914996, encodeId=0ce2914996bd, content=<a href='/topic/show?id=3123104096da' target=_blank style='color:#2F92EE;'>#MC-1#</a>&<a href='/topic/show?id=dad04542ede' target=_blank style='color:#2F92EE;'>#孤儿药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=157, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=104096, encryptionId=3123104096da, topicName=MC-1), TopicDto(id=45427, encryptionId=dad04542ede, topicName=孤儿药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59321624668, createdName=zb1235672, createdTime=Sat Jan 09 21:15:36 CST 2021, time=2021-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=914725, encodeId=4a01914e2565, content=有帮助, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ed775438914, createdName=ms6000000586787889, createdTime=Fri Jan 08 20:41:55 CST 2021, time=2021-01-08, status=1, ipAttribution=)]
    2023-12-20 ms8000001901220492 来自湖南省

    我家孩子也是这个病,两岁多了,有病友有群的吗?juan2356741791

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=2176053, encodeId=4b2521e605311, content=我家孩子也是这个病,两岁多了,有病友有群的吗?juan2356741791, beContent=null, objectType=article, channel=null, level=null, likeNumber=13, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a3648276345, createdName=ms8000001901220492, createdTime=Wed Dec 20 09:55:52 CST 2023, time=2023-12-20, status=1, ipAttribution=湖南省), GetPortalCommentsPageByObjectIdResponse(id=2122568, encodeId=5046212256802, content=我家孩子就是这个病,怎么才能买到这个药, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6e1c8524523, createdName=ms3000000756023345, createdTime=Wed Mar 29 22:11:17 CST 2023, time=2023-03-29, status=1, ipAttribution=湖北省), GetPortalCommentsPageByObjectIdResponse(id=1238713, encodeId=68871238e13e6, content=请问这个药哪里可以买到?, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=94958276361, createdName=ms6000002046775579, createdTime=Mon Aug 15 01:01:20 CST 2022, time=2022-08-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675248, encodeId=ce5816e524817, content=<a href='/topic/show?id=b9f214438ea' target=_blank style='color:#2F92EE;'>#PNP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14438, encryptionId=b9f214438ea, topicName=PNP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b29b27191603, createdName=cy0333, createdTime=Tue Mar 16 11:07:27 CST 2021, time=2021-03-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1365258, encodeId=d48813652589c, content=<a href='/topic/show?id=dfa045434e1' target=_blank style='color:#2F92EE;'>#孤儿药称号#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45434, encryptionId=dfa045434e1, topicName=孤儿药称号)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cd0d217, createdName=huiwelcome, createdTime=Sun Jan 10 11:07:27 CST 2021, time=2021-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=914996, encodeId=0ce2914996bd, content=<a href='/topic/show?id=3123104096da' target=_blank style='color:#2F92EE;'>#MC-1#</a>&<a href='/topic/show?id=dad04542ede' target=_blank style='color:#2F92EE;'>#孤儿药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=157, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=104096, encryptionId=3123104096da, topicName=MC-1), TopicDto(id=45427, encryptionId=dad04542ede, topicName=孤儿药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59321624668, createdName=zb1235672, createdTime=Sat Jan 09 21:15:36 CST 2021, time=2021-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=914725, encodeId=4a01914e2565, content=有帮助, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ed775438914, createdName=ms6000000586787889, createdTime=Fri Jan 08 20:41:55 CST 2021, time=2021-01-08, status=1, ipAttribution=)]
    2023-03-29 ms3000000756023345 来自湖北省

    我家孩子就是这个病,怎么才能买到这个药

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=2176053, encodeId=4b2521e605311, content=我家孩子也是这个病,两岁多了,有病友有群的吗?juan2356741791, beContent=null, objectType=article, channel=null, level=null, likeNumber=13, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a3648276345, createdName=ms8000001901220492, createdTime=Wed Dec 20 09:55:52 CST 2023, time=2023-12-20, status=1, ipAttribution=湖南省), GetPortalCommentsPageByObjectIdResponse(id=2122568, encodeId=5046212256802, content=我家孩子就是这个病,怎么才能买到这个药, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6e1c8524523, createdName=ms3000000756023345, createdTime=Wed Mar 29 22:11:17 CST 2023, time=2023-03-29, status=1, ipAttribution=湖北省), GetPortalCommentsPageByObjectIdResponse(id=1238713, encodeId=68871238e13e6, content=请问这个药哪里可以买到?, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=94958276361, createdName=ms6000002046775579, createdTime=Mon Aug 15 01:01:20 CST 2022, time=2022-08-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675248, encodeId=ce5816e524817, content=<a href='/topic/show?id=b9f214438ea' target=_blank style='color:#2F92EE;'>#PNP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14438, encryptionId=b9f214438ea, topicName=PNP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b29b27191603, createdName=cy0333, createdTime=Tue Mar 16 11:07:27 CST 2021, time=2021-03-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1365258, encodeId=d48813652589c, content=<a href='/topic/show?id=dfa045434e1' target=_blank style='color:#2F92EE;'>#孤儿药称号#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45434, encryptionId=dfa045434e1, topicName=孤儿药称号)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cd0d217, createdName=huiwelcome, createdTime=Sun Jan 10 11:07:27 CST 2021, time=2021-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=914996, encodeId=0ce2914996bd, content=<a href='/topic/show?id=3123104096da' target=_blank style='color:#2F92EE;'>#MC-1#</a>&<a href='/topic/show?id=dad04542ede' target=_blank style='color:#2F92EE;'>#孤儿药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=157, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=104096, encryptionId=3123104096da, topicName=MC-1), TopicDto(id=45427, encryptionId=dad04542ede, topicName=孤儿药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59321624668, createdName=zb1235672, createdTime=Sat Jan 09 21:15:36 CST 2021, time=2021-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=914725, encodeId=4a01914e2565, content=有帮助, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ed775438914, createdName=ms6000000586787889, createdTime=Fri Jan 08 20:41:55 CST 2021, time=2021-01-08, status=1, ipAttribution=)]
    2022-08-15 ms6000002046775579

    请问这个药哪里可以买到?

    0

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    2021-03-16 cy0333
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  7. [GetPortalCommentsPageByObjectIdResponse(id=2176053, encodeId=4b2521e605311, content=我家孩子也是这个病,两岁多了,有病友有群的吗?juan2356741791, beContent=null, objectType=article, channel=null, level=null, likeNumber=13, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a3648276345, createdName=ms8000001901220492, createdTime=Wed Dec 20 09:55:52 CST 2023, time=2023-12-20, status=1, ipAttribution=湖南省), GetPortalCommentsPageByObjectIdResponse(id=2122568, encodeId=5046212256802, content=我家孩子就是这个病,怎么才能买到这个药, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6e1c8524523, createdName=ms3000000756023345, createdTime=Wed Mar 29 22:11:17 CST 2023, time=2023-03-29, status=1, ipAttribution=湖北省), GetPortalCommentsPageByObjectIdResponse(id=1238713, encodeId=68871238e13e6, content=请问这个药哪里可以买到?, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=94958276361, createdName=ms6000002046775579, createdTime=Mon Aug 15 01:01:20 CST 2022, time=2022-08-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675248, encodeId=ce5816e524817, content=<a href='/topic/show?id=b9f214438ea' target=_blank style='color:#2F92EE;'>#PNP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14438, encryptionId=b9f214438ea, topicName=PNP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b29b27191603, createdName=cy0333, createdTime=Tue Mar 16 11:07:27 CST 2021, time=2021-03-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1365258, encodeId=d48813652589c, content=<a href='/topic/show?id=dfa045434e1' target=_blank style='color:#2F92EE;'>#孤儿药称号#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45434, encryptionId=dfa045434e1, topicName=孤儿药称号)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cd0d217, createdName=huiwelcome, createdTime=Sun Jan 10 11:07:27 CST 2021, time=2021-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=914996, encodeId=0ce2914996bd, content=<a href='/topic/show?id=3123104096da' target=_blank style='color:#2F92EE;'>#MC-1#</a>&<a href='/topic/show?id=dad04542ede' target=_blank style='color:#2F92EE;'>#孤儿药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=157, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=104096, encryptionId=3123104096da, topicName=MC-1), TopicDto(id=45427, encryptionId=dad04542ede, topicName=孤儿药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=59321624668, createdName=zb1235672, createdTime=Sat Jan 09 21:15:36 CST 2021, time=2021-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=914725, encodeId=4a01914e2565, content=有帮助, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ed775438914, createdName=ms6000000586787889, createdTime=Fri Jan 08 20:41:55 CST 2021, time=2021-01-08, status=1, ipAttribution=)]
    2021-01-08 ms6000000586787889

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