FDA专家小组建议批准ocriplasmin用于治疗玻璃体黄斑粘连
7月27日消息 - 环球医学据悉,美国食品和药物管理局(FDA)专家小组近日推荐ThromboGenics NV公司的ocriplasmin用于治疗玻璃体黄斑粘连——一种可导致失明的年龄相关性视力障碍。
FDA外部专家顾问委员会得出结论认为,该种商品名为Jetrea的注射用药物,在临床试验中帮助了足够多的人,以保证有利的审查,尽管有证据显示该药有致眼睛疼痛、肿胀和视力模糊等不利影响。
几位小组成员建议进行进一步研究,以监控该药的安全性并更充分地确定该药的有效性。
这些建议现在将被美国卫生监管部门纳入考虑,他们必须决定是否批准该药在美国出售。
该公司已与诺华公司的眼科部门——爱尔康公司达成一项协议,由爱尔康在美国以外的40个国家销售ocriplasmin。
ThromboGenics计划由自己在美国销售该药物。(环球医学)
原文:
FDA panel endorses drug for age-related eye problem
A Food and Drug Administration panel on Thursday recommended ThromboGenics NV's ocriplasmin as a treatment for vitreomacular adhesion, an aging-related vision problem that can lead to blindness.
The FDA advisory committee of outside experts concluded that the injectable drug, marketed under the brand name Jetrea, helped enough people in clinical trials to warrant a favorable review, despite evidence of adverse effects including eye pain, swelling and blurred vision.
Several panel members recommended further studies to monitor safety and determine more fully the drug's effectiveness.
The recommendations will now be considered by U.S. health regulators, who must decide whether to approve the treatment for sale in the United States.
The Belgian biotech company's shares closed 4.82 percent lower at 23.30 euros before the panel voted on the drug.
The company has secured a deal to sell ocriplasmin in 40 countries outside the United States through Novartis AG's opthalmic division, Alcon.
ThromboGenics plans to market the product itself within the United States.
相关链接:http://www.reuters.com/article/2012/07/26/us-usa-fda-ocriplasmin-idUSBRE86P1ND20120726
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