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


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Merck expects to have 10 million courses of treatment ready by the end of 2021

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

According to a joint announcement by Merck and its partner Ridgeback Biotherapeutics, the drugmaker submitted an emergency use authorization (EUA) application for mollupiravir to the US Food and Drug Administration (FDA).


According to Merck, the drug is said to treat mild to moderate cases of the virus in adults who are at risk of progressing to more severe cases or requiring hospitalization.

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

The company submitted for emergency approval after positive results from a clinical trial evaluating non-hospitalized adult patients at high risk for serious illness due to health problems such as obesity, diabetes or heart disease.

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Merck & Ridgeback Biotherapeutics said: Initial results shown to patients Those who received the drug within five days of COVID-19 symptoms had about half the rate of hospitalization and death than those who received the dummy pill.

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Merck CEO Robert M. “The extraordinary impact of this pandemic demands that we proceed with unprecedented urgency, and that’s what our teams have done by submitting this application to the FDA for molnupiravir within 10 days of receiving the data,” Davis said.

An antiviral pill that people could take at home to ease their symptoms and speed recovery could help ease the crushing caseload on US hospitals and contain outbreaks in poor countries with weak health care systems.

The US government is committed to buying enough pills to treat 17 million people, assuming the FDA authorizes the drug.

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

It also has contracts with governments around the world.

AssociationFeatherEd Press contributed to this report.

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