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Merck applies for FDA approval for its antiviral COVID-19 drug
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Merck applies for FDA approval for its antiviral COVID-19 drug

Merck develops oral antiviral medicine. Emergency Authorization application submitted.

Where: United States

The Facts

On October 11th, Merck announced it had applied to the FDA for Emergency Use Authorization (EUA) of its oral antiviral COVID-19 medicine – Molnupiravir.

Molnupiravir is an investigational drug for treating mild-to-moderate COVID-19 in adults at an increased risk of developing severe COVID-19.

Merck applied for FDA approval following favorable results in an interim analysis of its Phase 3 clinical trial for Molnupiravir.

The clinical study found that the drug reduced the risk of hospitalization or death in adults with mild to moderate COVID-19 at high risk of severe disease by approximately 50%.

CEO and President of Merck, Robert Davis, stated, “We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible.”

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