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CIDRAP,10月11日,Merck applies for approval of first COVID-19 antiviral pill

编译者:YUTING发布时间:Oct 15, 2021点击量:44 来源栏目:最新研究

Today, pharmaceutical giant Merck submitted an emergency use authorization (EUA) application to the Food and Drug Administration (FDA) for molnupiravir, its oral antiviral medication, for the treatment of mild to moderate COVID-19 in adults at risk for severe disease.

This category includes patients over 60 years and those diagnosed as having obesity, diabetes, or heart disease.

The drug, named after Thor's hammer in Norse mythology, would be the first pill authorized by the FDA to treat COVID-19. Other antivirals used to fight COVID-19 have to be injected or administered intravenously. Merck has previously said that, if approved, the company is ready to supply the US government with 1.7 million doses of the antiviral.

The submission is based on positive results from a phase 3 trial of the drug, which showed that molnupiravir reduced the risk of hospitalization or death by approximately 50%.

"The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data," said Robert M. Davis, Merck chief executive officer and president, in a company press release.

The suggested use of molnupiravir would be four capsules twice a day for 5 days.

COVID-19 cases continue to drop

According to the New York Times tracker, the country recorded 96,549 COVID-19 cases yesterday and 2,000 deaths. The newspaper said cases are dropping most significantly in Southern states that saw the biggest activity during the nation’s fourth wave this summer, which was fueled by the Delta (B1617.2) variant.

Florida, for example, is averaging fewer than 4,000 new cases a day, down from more than 20,000 a day at the end of August.

Northern and western states, including Alaska, Montana, North Dakota, Wyoming, and Minnesota, lead the nation in recent cases per capita; Minnesota's daily case counts increased 36% in the last 2 weeks.

The 7-day average of new daily COVID-19 cases is 95,926, with 1,778 daily deaths, according to the Washington Post tracker. New daily cases fell 10.1% in the past week, deaths fell 6.8%, and hospitalizations fell 8.2%.

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