The European Medicines Agency has issued a positive opinion for the investigational COVID-19 antibody cocktail (casirivimab with imdevimab) developed by Regeneron (NASDAQ:REGN).

欧洲药品管理局(European Medicines Agency)对Regeneron公司开发的新型冠状病毒抗体鸡尾酒(casirivimab + imdevimab)发布了积极意见。

The decision by the Committee for Medicinal Products for Human Use of EMA will pave the way for the therapy known as REGEN-COV in the U.S. to receive marketing authorization in the 27-member bloc.

EMA人用药品委员会的这一决定，将为REGEN-COV在美国获得欧盟的上市许可铺平道路。

Until then, the member states can use the positive CHMP opinion to make national decisions about the use of the therapy.

在此之前，成员国可以利用CHMP的积极意见，就该疗法的使用作出国家决定。

The recommendation allows the use of REGEN-COV in confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of developing severe COVID-19.

该建议允许在确诊的COVID-19患者中使用REGEN-COV，这些患者不需要补充氧气，且有发展为严重COVID-19的高风险。

For the development and distribution of the treatment, Regeneron has U.S. rights while Roche (OTCQX:RHHBY) owns rights outside the U.S.

对于该疗法的开发和分销，Regeneron拥有美国的权利，而罗氏(Roche)拥有美国以外的权利

The FDA granted the emergency use authorization for REGEN-COV in November 2020 in the treatment of mild to moderate COVID-19 in adult and pediatric patients.

FDA于2020年11月批准了REGEN-COV的紧急使用许可，用于治疗轻至中度COVID-19的成人和儿童患者。