有一种遗传性疾病可导致患者对阳光不耐受，目前欧洲的这一疾病患者将很快会有一种新的治疗选择，澳大利亚Clinuvel制药公司的一款用于该种疾病的药物已获得欧洲药品管理批准推荐。
这家生物科技公司正寄希望于其药物Scenesse，这是首款预防红细胞生成性原卟啉症(EPP)成人患者光毒性的药物。在暴露于阳光之后，EPP患者会感觉到暴露于阳光的皮肤有一种刺痛感，延长暴露可导致一种令人伤残的疼痛，随后出现红肿。
Scenesse可通过刺激一种叫真黑色素的产生而抵抗这一疾病的影响，真黑色素可以保护皮肤，这种疾病在欧盟影响人数不到1万人。
欧洲药品管理局表示，其新药专家委员会根据特殊情况及实施安慰剂对照试验反映的困难，已决定推荐批准Scenesse。欧洲药品管理局人用医药产品委员会(CHMP)的上市许可推荐通常会在几个月内得到欧盟的支持
美国Clinuvel 公司研发的SCENESSE药物治疗白癜风皮肤病的情况，现简要综述如下：
1、据报道，对SCENESSE 的临床研究，原本是用于治疗红细胞生成性原卟啉病（erythropoietic protoporphyria，EPP）的。EPP病属于常染色体显性遗传病，与亚铁螯合酶活性降低有关。由于亚铁螯合酶缺乏，引起原卟啉在骨髓和红细胞中积聚。该病的特征是在儿童期或青春期发病，皮肤光过敏，日晒后，主要是疼痛，红斑和炎性肿胀。该药的作用是增加皮肤黑色素的含量和阻挡阳光里的紫外线对皮肤的的辐射损伤。药用原理是：通过向皮下植入约一粒米大小的溶解性药物（α-MSH的 刺激素），刺激皮肤细胞(黑色素细胞)进而产生和释放黑色素。用药两个月， 可使皮肤增加深棕色的色素沉着，还不存在紫外线辐射对皮肤的有害影响的风险。
2、依据上述药理作用，研发该药的美国Clinuvel 公司于2010年起，冒险的将该药进一步引入治疗皮肤色素脱失症----白癜风皮肤病。据该公司网站报道，20多个临床试验 、超过700名患者已经接受使用SCENESSE药物。结果表明，患者的药物耐受性良好。在治疗EPP病的试验中，SCENESSE药物被证明能减少光毒性反应的发生率和严重程度。在治疗白癜风皮肤病方面，公司仅阐明，将对该药物与窄波紫外线光疗(NB- UVB) 的联合治疗效果进行实验评估 。实验的目的是确定SCENESSE药物是否可以减少NB-UVB光疗激活白斑病变区的黑色素细胞所用的剂量和时间。 2012年初，该药申请上市欧洲市场时，美国著名记者、白癜风团体的发言人李·托马斯曾同时就SCENESSE作为潜在的治疗白癜风的药物问题，采访过Clinuvel公司首席执行官菲利普·沃根博士（Dr Philippe Wolgen ）。但到目前为止，仍未见到临床实验的评估报告面市。如果治愈白癜风，到底是 UVB光疗的作用，还是SCENESSE药物的作用，恐怕难以分清说明。
3、综上所述，相信该药用于治疗白癜风的实验报告终归会面市的，疗效有望客观说明。但笔者认为不会是治疗白癜风的特效药。只是刺激α-MSH 促进黑色素生成的药物之一。有可能属于主治EPP病，对白癜风有一定辅助疗效的药物，类似普特彼他克莫司软膏的研发成果应用。国内2007年就有硕士学位论文《刺蒺藜对α-MSH 表达的影响及其复方治疗白癜风的疗效分析》。这表明许多医学人士在探索、研究各种刺激 α-MSH 促进黑色素生成的药物，不属新课题。
SCENESSE (INN: afamelanotide) is Clinuvel's proprietary first-in-class photoprotective drug. The drug has been approved for marketing authorisation under exceptional circumstances by the European Medicines Agency for the orphan disease erythropoietic protoporphyria (EPP). Further studies of SCENESSE are underway as a repigmentary agent in vitiligo.
SCENESSE (pronounced "sen-esse") acts by increasing the levels of melanin in the skin; and shields against UV radiation (UVR) and sunlight. SCENESSE is delivered via a subcutaneous dissolving implant approximately the size of a grain of rice. Increased pigmentation of the skin appears after two days and lasts up to two months.
Alpha-Melanocyte Stimulating Hormone (α-MSH) is a naturally occurring peptide hormone which is released by skin cells in response to the stimulation by ultraviolet radiation (UVR). α-MSH has a very short half life (seconds) in the blood stream, sufficient to reach and stimulate other skin cells (melanocytes) which in turn produce and release melanin, a dark brown pigment. Melanin is known for its photoprotective effect.
The skin's response to damage from UV radiation - Human tanning response
SCENESSE is a chemical analogue of α-MSH and is a linear peptide with 13 amino acids. Two amino acids present in α-MSH have been changed and amplified to produce afamelanotide. This small change creates a more stable molecule with increased potent biologic effects and a longer half life (minutes). SCENESSE increases melanin content of the skin without exposure of the skin to the damaging effects of UVR.
Clinuvel is currently trialing SCENESSE in a range of light and UV related skin disorders (photodermatoses) and as a repigmentation therapy in vitiligo. It is proposed that SCENESSE will provide prophylactic treatment to patients suffering from photodermatoses by stimulating melanin to act as a photoprotective filtering the impact of UV to the skin. In vitiligo the drug is being eva luated in combination with narrowband ultraviolet B phototherapy (NB-UVB).
Over 900 patients have been treated with SCENESSE in more than 20 clinical trials over several indications. Results to date suggest that the drug is well tolerated. In EPP trials, SCENESSE has been shown to reduce the incidence and severity of phototoxic reactions.
Biomimicry of the human tanning response
Clinuvel Pharmaceuticals Ltd is an ethical pharmaceutical company focused on providing photoprotective care of the skin. Clinuvel is working closely with global regulatory agencies to develop SCENESSE as a prescriptive drug. Clinuvel has been developing and testing SCENESSE since 2000. Our development is focused on the SAFE and controlled administration of the drug substance.

SCENESSE