There Merck’s antiviral pill against Covid arrives on the FDA desk. This was announced by the US company together with Ridgeback Biotherapeutics, with which the drug was developed: “Today we submitted an emergency use authorization application to the US FDA for our oral antiviral treatment for Covid-19”, they communicate. Molnupiravir is proposed for the treatment of mild to moderate Covid-19 in adults at risk of progression to severe disease and hospitalization.
“If licensed, it could be the first oral antiviral drug for treatment“of the disease caused by the Sars-CoV-2 coronavirus, the two companies underline in a note, adding that they are committed to working” actively with regulatory agencies around the world to submit applications for emergency use or authorization. to be placed on the market in the coming months “for the drug.
Application submission in the United States is based on the positive results of a planned interim review of the Phase 3 Move-Out clinical trial. Analysis that molnupiravir reduced the risk of hospitalization or death by approximately 50%.
“The extraordinary impact of this pandemic requires that we move with unprecedented urgency, and that’s 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. , CEO and president of Merck. The submission to the FDA “is a critical step towards the availability of molnupiravir for people who could benefit from an oral antiviral that can be taken at home shortly after diagnosis,” added Wendy Holman, CEO of Ridgeback Biotherapeutics.
In view of a potential green light, Merck says it has begun producing unsafe molnupiravir and expects to produce 10 million treatment cycles by the end of 2021.
Molnupiravir is also being evaluated for post-exposure prophylaxis in the Phase 3 Move-Ahead trial, which evaluates the efficacy and safety of the antiviral in preventing the spread of Covid-19 within families.