FDA需要制药商进行另一项关于Vyndaqel的试验
6月20日消息 - 环球医学据悉,辉瑞公司表示,美国食品和药物管理局(FDA)已要求该公司对其神经退行性疾病治疗药物Vyndaqel进行另一项临床试验。
辉瑞公司称,FDA需要其研究Vyndaqel治疗转甲状腺素蛋白家族性淀粉样多发性神经病的疗效,转甲状腺素蛋白家族性淀粉样多发性神经病是一种可能会致命的遗传性疾病,通常用肝移植来治疗。
Vyndaqel,或称tafamidis,是旨在延缓转甲状腺素蛋白家族性淀粉样多发性神经病(TTR-FAP)患者神经损害的药物。去年11月,欧盟监管机构批准了Vyndaqel的使用,辉瑞公司说,美国目前没有批准任何治疗此病的药物。全球约有8000人罹患TTR-FAP。(环球医学)
原文:
FDA Wants Another Vyndaqel Trial
Pfizer Inc. said that the Food and Drug Administration has asked the company to run another clinical trial of its neurodegenerative disease drug Vyndaqel.
The FDA wants the drugmaker it to study the effectiveness of Vyndaqel as a treatment for transthyretin familial amyloid polyneuropathy, a potentially fatal genetic condition normally treated with a liver transplant, Pfizer said.
Vyndaqel, or tafamidis, is a pill intended to delay neurological impairment in people with the condition, also known as TTR-FAP. European Union regulators approved the use of Vyndaqel in November, and Pfizer said there are no approved drugs for the condition in the U.S. About 8,000 people have TTR-FAP worldwide.
相关链接:http://www.dddmag.com/news/2012/06/fda-wants-another-vyndaqel-trial
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