If authorized, the drug manufactured by Merck and Ridgeback Biotherapeutics would be the first oral antiviral treatment to combat Covid-19. It comes in capsule form.
Merck said it is seeking permission for the capsules to treat infected adults at risk of developing serious Covid-19 disease or hospitalization. Its submission is based on a study that was stopped in the meantime because the drug worked so well in more than 700 patients who were randomly assigned to either molnupiravir or placebo.
“In preliminary analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients receiving molnupiravir were either hospitalized or died by day 29 after randomization, compared with 14.1% of placebo-treated patients. “says the company. said in a statement.
“Up to and including day 29, no deaths were reported in patients receiving molnupiravir compared to eight deaths in patients receiving placebo.” None of the volunteers in the trial had been vaccinated.
“The extraordinary impact of this pandemic requires us to move at an unprecedented rate, 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 said. CEO and President Robert Davis in resignation.
Data from the trial have not yet been peer-reviewed or published.
“Merck has produced molnupiravir in the danger zone and expects to produce 10 million courses of treatment by the end of 2021, and more courses are expected to be produced by 2022,” the company said.
It has already sold 1.7 million treatment courses to the US government. The company said it will offer incremental pricing to provide access around the world and will work with generic drug manufacturers to accelerate accessibility to low- and middle-income countries.
At a White House covid-19 briefing last week, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, described the trial results as “very encouraging”, but said the drug should be scrutinized by the FDA.
“It is very important that this now goes through the usual process of carefully examining the data from the Food and Drug Administration both for effectiveness but also for safety, because when you introduce a new compound, safety is very important,” Fauci said and noted that vaccines continue to be “our best tool against Covid-19” by preventing infection and disease rather than treating it.