在欧洲丙型肝炎药物成功

StephenW

Gilead stock hits record after hepatitis C drug's success in Europe

Associated Press
Posted:   11/22/2013 09:21:24 AM PST | Updated:   a day ago

FOSTER CITY -- Gilead Sciences (GILD) said Friday that an advisory committee in the European Union is recommending that its hepatitis C drug Sovaldi receive marketing approval.

The drug is still being reviewed, but the recommendation could improve the chances it will be approved. Gilead says Sovaldi, or sofosbuvir, could be available in the EU during the first quarter of 2014.

The drug is also being reviewed by U.S. regulators. Food and Drug Administration advisers recommended approval in October, and the FDA is expected to make a decision on Sovaldi by Dec. 8.

Current treatments for hepatitis C can take up to a year of therapy and only cure about three out of four patients. Sovaldi is a pill taken once per day, and in clinical trials it cured up to 90 percent of patients infected with the most common form of the virus in just 12 weeks. Gilead acquired the hepatitis C drug in 2012 when it bought Pharmasset for $11.1 billion.

StephenW

美联社
发表于： 2013年11月22日上午九时21分24秒的PST |发布时间：一小时前

FOSTER CITY  - 吉利德科学（ GILD ）周五表示，欧盟一个咨询委员会，建议其丙型肝炎药物Sovaldi获得上市批准。

该药物仍在审查，但建议可以改善它会被批准的机会。吉利德说Sovaldi ，或sofosbuvir ，可以提供在欧盟2014年第一季度。

该药物也被美国监管机构审查。食品和药物管理局顾问建议批准在十月，和FDA预计在12月8日作出的Sovaldi决定。

目前的治疗丙型肝炎的可能需要长达一年的治疗，只有治愈大约四分之三的患者。 Sovaldi是每天服用一次一丸，并在临床试验中它治愈多达90 ％的患者在短短12周内感染病毒的最常见形式。吉利德收购丙型肝炎药物在2012年的时候收购了PHARMASSET以$ 11.1十亿。