日本成为批准使用诺华银屑病药物的首个国家

  周五，瑞士制药公司诺华表示，他们已经赢得了银屑病药物Cosentyx在日本市场的批准，而日本也由此成为了第一个批准商业化使用该药物的国家。
  日本允许诺华在国内售卖药物secukinumab，即Cosentyx，用于治疗寻常性银屑病和银屑病关节炎的成年患者，以及对其它药物无反应的患者。目前有专家认为该药物具有巨大的潜在市场价值，大约每年会赢得10亿至25亿美元的收入。据估计，世界上有3%的人口，大约1.23亿人口都遭受银屑病的困扰，其中在日本就有40万银屑病患者。
  寻常性银屑病是一种引发皮肤变厚、发痒的疾病，而当疾病发生同时关节的改变也往往会引发关节的僵硬和疼痛。诺华在一项声明中指出，在该药物进行临床试验阶段，70%的病人的银屑病症状都会得到改善或者完全被清除；而今年11月欧洲药物监管机构推荐药物Cosentyx在日本的批准也使得该药物作为治疗银屑病的第一批药物进入市场。
  与此同时，美国食品及药物管理局也希望在2015年年初对该药物进行批准。Cosentyx是一种人类单克隆抗体，其可以中和银屑病患者机体中较高水平的特殊蛋白。（转化医学网360zhyx.com）
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Swiss pharmaceutical company Novartis said Friday it has won approval to market its Cosentyx psoriasis treatment in Japan, making it the first country to authorise commercialisation of the drug.
The Japanese decision allows Novartis to sell secukinumab, sold under the name Cosentyx, to adult patients suffering psoriasis vulgaris and psoriatic arthritis, and who aren't responding to other medication.
The drug is considered by experts to have potentially enormous market value of between $1 billion and $2.5 billion annually. It's estimated 3 percent of the world's population—or over 125 million people—suffer from some form of psoriasis, including over 400,000 individuals in Japan alone.
Psoriasis vulgaris is a skin disease provoking thick, itchy lesions, while the articular variant causes stiffness and pain in joints.
Novartis said in a statement that during clinical testing of the drug, 70 percent of patients experienced improvement or complete clearing of their psoriasis symptoms.
Approval in Japan follows the recommendation by European drug regulators in November that Cosentyx be approved for sale as a first-line treatment of psoriasis.
Similarly, the US Food and Drug Administration is expected to approve the medication in early 2015 after its panel of experts issued a similarly positive recommendation in October.
Novartis says Cosentyx is a human monoclonal antibody that neutralises a protein present in high levels of concentration in psoriasis patients.