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10/11/2021 12:07 pm  #1


Merck seeks FDA emergency use authorization for antiviral Covid-19 ...

treatment molnupiravir

Merck said today it is seeking US Food and Drug Administration emergency use authorization for its experimental antiviral Covid-19 treatment, molnupiravir.

If authorization is granted, the drug, made by Merck and Ridgeback Biotherapeutics, would be the first oral antiviral treatment to fight Covid-19. It comes in capsule form.

 Merck said it is asking for authorization for the capsules to treat infected adults who are at risk of progressing to severe Covid-19 disease or hospitalization.

Its submission is based on a study that was stopped at the interim point because the drug was working so well in more than 700 patients randomly assigned to take either molnupiravir or a placebo.

At a White House Covid-19 briefing last week, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the trial results "very encouraging," but said the drug needs close scrutiny by the FDA.

 

10/12/2021 7:37 pm  #2


Re: Merck seeks FDA emergency use authorization for antiviral Covid-19 ...

An authorization from the U.S. Food and Drug Administration could help change clinical management of COVID-19 as the pill can be taken at home.

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