请大家持续关注CLINUVEL公司治疗BB新药的FDA临床验证进展！！！

shuidebowen2017

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

关注下

shuidebowen2017

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

Afamelanotide 阿美诺肽  黑素细胞皮质素受体激动药

美丽依旧

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

谢谢分享，希望此药早曰上市

X先生

耐心等待那一天

                               
登录/注册后可看大图

雨过会更好

非常感谢楼主的分享，愿白白早曰被坆克

释怀

感谢分享，给我们希望。愿此药早日上市！

雪尘飞扬

曙光。

naixin

有点小激动

                               
登录/注册后可看大图

过无采

希望在明天

                               
登录/注册后可看大图

从新开始

不是我悲观是前两年对新药希望太大

凯瑞

感谢分享

山东_阿川

去年就有消息和关注了吧？！好像并没有决定性治疗