双语日报 | 辉瑞新冠口服药允许仿制药生产,正在向美国申请紧急授权!

Pfizer Inc said on Tuesday it is seeking US authorization of its experimental antiviral COVID-19 pill that cut the chance of hospitalization or death for adults at risk of severe disease by 89% in a clinical trial.

辉瑞公司周二表示,正在寻求美国授权其实验性抗病毒冠状病毒药片,该药片在一项临床试验中将有严重疾病风险的成年人住院或死亡的机会降低了89%。

Pfizer said it completed submission of its application for emergency use authorization (EUA) of the drug, Paxlovid, with the US Food and Drug Administration, including data from the drugmaker's clinical trial.

辉瑞(Pfizer)表示,已向美国食品和药物管理局(fda)提交了Paxlovid的紧急使用授权(EUA)申请,其中包括该制药商的临床试验数据。

The oral drug could be a promising new weapon in the fight against the pandemic,

口服药物可能成为抗击这种流行病的一种很有前途的新武器,

as it can be taken as an early at-home treatment to help prevent COVID-19 hospitalizations and deaths.

因为它可以作为一种早期的家庭治疗,以帮助防止冠状病毒住院和死亡。

It could also become a important tool in countries and areas with limited access to vaccines or low vaccination rates.

在疫苗接种机会有限或疫苗接种率低的国家和地区,它也可能成为一个重要工具。

It is not immediately clear when US regulators will rule on Pfizer's application.

目前尚不清楚美国监管机构何时会对辉瑞的申请做出裁决。

Merck & Co and Ridgeback Biotherapeutics, which are developing a competing pill, molnupiravir, completed their EUA submission on Oct 11.

10月11日,默克公司和Ridgeback生物治疗公司完成了EUA提交,这两家公司正在开发一种竞争药物molnupiravir。

A panel of outside advisers to the FDA will meet to consider that application on Nov 30.

FDA的一个外部顾问小组将于11月30日开会审议这一申请。

It is expected to be available this year.

预计它将在今年上市。

"We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients,

“我们正在以最快的速度努力将这种潜在的治疗方法送到患者手中,

and we look forward to working with the US FDA on its review of our application, along with other regulatory agencies around the world,"

我们期待着与美国食品和药物管理局以及世界各地的其他管理机构一起审查我们的申请。”

Pfizer Chief Executive Albert Bourla said in a news release.

辉瑞执行长Albert Bourla在新闻稿中称。


文章来源:中英双语外刊阅读

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