shuidebowen2017 发表于 2017-6-6 00:19:44

请大家持续关注CLINUVEL公司治疗BB新药的FDA临床验证进展!!!

请诸位深受BB之害的朋友持续关注CLINUVEL PHARMACEUTICALS这家公司的新药FDA验证进展。如果有网友已经发现了该公司及药物,请忽略我的帖子。


通过其网站的最新信息来看,SCENESSE® (afamelanotide 16mg)是一种正在进行美国FDA二期临床试验的药物,对恢复BB皮肤有明显效果。CLINUVEL已经获得了欧洲的批准,可以作为处方药经医生提供给患者。


可惜大家还要耐心等待几年,因为美国FDA的新药上市审批流程非常严格,一种新药要经过三个阶段的临床试验,有可能耗时长达10年甚至更多。CLINUVEL自2011年开始临床验证,现已6年。2015年开始二期临床验证,现已2年,理论上最迟明年即可完成二期临床试验。三期临床验证到最后上市,还要几年的时间。


我爱人深受BB之害,因此我经常在国外网站搜索些治疗的办法。偶然发现了这家公司,于是赶紧分享给大家。希望同样深受其害的病友千万不要气馁灰心,这么多年都苦熬过来,还差这几年时间吗?


同时希望论坛上诸位专家持续关注此药物以及具体治疗方法的进展,以您的专业知识与爱心为广大病友加油鼓气。


由于本人英文水平与时间有限,无法详细翻译这家公司的所有信息,请有能力的网友访问网址 3w点clinuvel.com/en/vitiligo

牛蛙 发表于 2017-6-6 00:24:21

关注下

shuidebowen2017 发表于 2017-6-6 00:24:38

What is SCENESSE® (afamelanotide 16mg)?
SCENESSE® (afamelanotide 16mg) is a first-in-class therapeutic developed by CLINUVEL, with the active ingredient (or INN) afamelanotide. Afamelanotide is a synthetic tridecapeptide and a structural analogue of α-melanocyte stimulating hormone (α-MSH) which activates eumelanin of the skin, the dark pigment which is known to provide photoprotection (offering skin protection against light and UV radiation).

What conditi** does CLINUVEL aim to treat with SCENESSE® (afamelanotide 16mg)? What are your 'target indicati**'?
With its unique expertise in understanding the interaction of light and human skin, CLINUVEL has identified groups of patients with a clinical need for photoprotection and repigmentation. At present the Company is focused on the following indicati**:

Erythropoietic protoporphyria (EPP) - a rare genetic storage disorder that causes severe phototoxicity (anaphylactoid reacti** and second degree burns).
Vitiligo - a pigmentary disorder.
How does SCENESSE® work? What is the mechanism of action of SCENESSE®?
SCENESSE® mimics the body’s natural ability to produce melanin, the pigment in skin.

Afamelanotide, the active ingredient in SCENESSE®, is a structural analogue of α-melanocyte stimulating hormone (α-MSH) and is able to bind predominantly to the to the melanocortin-1 receptor (MC1R), mimicking the compound’s pharmacological activity by activating the synthesis of eumelanin by the MC1R receptor.

Eumelanin is able to contribute to photoprotection through different mechanisms including:

Broad band absorption of UV and visible light, where eumelanin acts as a photoprotective; and
Antioxidant activity.
To read more, please see the following page - SCENESSE® mechanism of action.

shuidebowen2017 发表于 2017-6-6 00:25:17

Afamelanotide 阿美诺肽黑素细胞皮质素受体激动药

美丽依旧 发表于 2017-6-6 00:36:21

感谢分享,希望你们有文化有能力的多多关注一下国外的信息,再分享给论坛让更多的人知道,非常感谢

legend05602 发表于 2017-6-6 06:14:39

谢谢分享,希望此药早曰上市

X先生 发表于 2017-6-6 06:29:31

耐心等待那一天http://www.bbsls.net//mobcent//app/data/phiz/default/01.png

雨过会更好 发表于 2017-6-6 06:29:40

非常感谢楼主的分享,愿白白早曰被坆克

释怀 发表于 2017-6-6 07:15:22

感谢分享,给我们希望。愿此药早日上市!

雪尘飞扬 发表于 2017-6-6 08:11:06

曙光。

naixin 发表于 2017-6-6 08:15:08

有点小激动http://www.bbsls.net//mobcent//app/data/phiz/default/16.png

过无采 发表于 2017-6-6 08:23:50

希望在明天http://www.bbsls.net//mobcent//app/data/phiz/default/59.png

从新开始 发表于 2017-6-6 08:45:48

不是我悲观是前两年对新药希望太大

凯瑞 发表于 2017-6-6 09:15:40

感谢分享

山东_阿川 发表于 2017-6-6 09:16:52

去年就有消息和关注了吧?!好像并没有决定性治疗
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