诺华治疗肢端肥大症长效药物获得FDA批准

2014-12-18 佚名 生物谷

美国FDA最近批准了诺华公司开发的用于治疗罕见疾病肢端肥大症的生长激素类药物Signifor登陆美国市场。这一药物也是继Sandostatin后,诺华公司在该领域开发的另一种主打产品。Sandostatin于今年失去专利保护。因此,诺华公司希望Signifor的批准能够填补公司在这一市场上的空白。 Signifor是一种肌肉注射用药物,这种药物能够结合患者体内的生长激素抑制素受体,进而下调患

美国FDA最近批准了诺华公司开发的用于治疗罕见疾病肢端肥大症的生长激素类药物Signifor登陆美国市场。这一药物也是继Sandostatin后,诺华公司在该领域开发的另一种主打产品。Sandostatin于今年失去专利保护。因此,诺华公司希望Signifor的批准能够填补公司在这一市场上的空白。

Signifor是一种肌肉注射用药物,这种药物能够结合患者体内的生长激素抑制素受体,进而下调患者体内的生长激素和胰岛素类似生长因子-1(IGF-1)的表达水平,从根本上改善肢端肥大症患者病情。而此前这一药物已经进行过两次临床三期研究,并达到了其预期终点,显著降低了患者的生长激素和IGF-1水平。此前,Signifor已经被批准用于治疗肾上腺皮质机能亢进症。

据统计,目前全世界每一百万人中就有六十个人患有肢端肥大症。然而,由于检测技术的限制,在未来几年,肢端肥大症的发病率有可能增大五倍之多!肢端肥大症不仅会导致患者的身体发育出现异常,由于体内激素水平的异常分泌,甚至会导致患者死亡的严重后果。因此,市场上也急需有效的治疗方案。诺华公司的肿瘤部门负责人Bruno Strigini评价说,此次FDA批准诺华公司的Signifor用于治疗肢端肥大症患者,为患者减轻病情痛苦提供了一种新的有效措施。

不过,诺华公司可能无法在这一领域独占鳌头。罗氏公司去年与Chiasma公司签订了一项价值近6亿美元的合作协议,共同进行治疗此类疾病药物的临床三期研究。这一产品被认为将会改变目前市场格局。

近年来,诺华公司在其研发工作上可以说是不惜血本。公司仅2013年就向研发领域投入了99亿美元的经费,约占其总营业额的17%左右。目前,诺华公司共有14种药物在研,公司希望未来四年内这些药物将为诺华公司带来超过10亿美元的进账。

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    2015-09-12 bugit
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