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Deseret News 11 October, 2021 - 04:53pm

Merck seeks FDA emergency use authorization for antiviral Covid-19 treatment molnupiravir

CNN 12 October, 2021 - 02:30am

The filing comes shortly after data from a late-stage study showed that the antiviral drug, molnupiravir, cut the risk of hospitalization or death by about 50% in high-risk people with mild to moderate Covid-19. 

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Merck asks FDA to authorize anti-COVID pill for emergency use

Fox Business 12 October, 2021 - 02:30am

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Drugmaker Merck asked federal health officials Monday to greenlight its experimental pill against COVID-19, which could make history as the first oral antiviral medicine to treat the harrowing virus. 

The drugmaker submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for molnupiravir, according to a joining announcement from Merck and its partner Ridgeback Biotherapeutics. 

The drug is said to treat mild-to-moderate cases of the virus in adults who are most at risk for progressing to more severe cases or being hospitalized, according to Merck. 

If cleared by the Food and Drug Administration — a decision that could come in a matter of weeks — it would be the first pill shown to treat COVID-19. All other FDA-backed treatments against the disease require an IV or injection. 

The company submitted for emergency approval following positive results from a clinical trial evaluating nonhospitalized adult patients considered high risk for severe disease because of health problems such as obesity, diabetes or heart disease. 

Merck and Ridgeback Biotherapeutics said early results showed patients who received the drug within five days of COVID-19 symptoms had about half the rate of hospitalization and death as those who received a dummy pill. 

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"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," Merck CEO Robert M. Davis said. 

An antiviral pill that people could take at home to reduce their symptoms and speed recovery could prove groundbreaking, easing the crushing caseload on U.S. hospitals and helping to curb outbreaks in poorer countries with weak health care systems. 

The U.S. government has committed to purchasing enough pills to treat 1.7 million people, assuming the FDA authorizes the drug.

In anticipation of federal approval, Merck expects to produce 10 million courses of treatment by the end of 2021, 

It also has has contracts with governments worldwide. 

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Merck seeks US authorisation for Covid-19 tablet

The Straits Times 12 October, 2021 - 02:30am

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