Merck said Monday it is looking for US FDA (Food and Drug Administration) emergency procedure approval for its investigational antiviral Covid-19 treatment, molnupiravir.
If approval is granted, the drug, prepared by Merck and Ridgeback Biotherapeutics, would be the first-ever oral antiviral treatment to fight Covid-19. It approaches in capsule form.
Merck’s statement on FDA approval and further process
Merck said it is requesting approval for the capsules to treat infected adults who are at risk of succeeding in severe Covid-19 disease or hospitalization. Its proposal is grounded on research that was clogged at the intervening point because the drug was functioning so well in more than 700 patients casually given to take either molnupiravir or a placebo.
This firm said in a statement that
“At the temporary analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 ensuing randomization, matched with 14.1% of placebo-treated patients,”
“Through Day 29, no deaths were marked in patients who received molnupiravir, as paralleled to eight deaths in patients who received placebo.” None of the volunteers in the experiment had been vaccinated.
Merck CEO and President Robert Davis said in the statement that-
“The unexpected influence of this pandemic weights that we move with unparalleled insistence, and that is what our teams have done by acquiescing this tender for molnupiravir to the FDA within 10 days of getting the data,”
Data from the trial has not yet been pre-reviewed or published.
The firm further dais that-
“Merck has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with more progresses probable to be produced in 2022,”
It has already sold 1.7 million treatment courses to the US government. The firm said it will provide tiered pricing to provide access all over the world and will work with universal drug makers to rapidly be available to low to middle-income countries.
Last week, Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, at a White House Covid-19 briefing, called the trial results “very promising,” but said the drug needs close analysis by the FDA.
“It is very vital that this now must go from side to side the usual process of careful examination of the data by the Food and Drug Administration both for efficiency, but also for safety, because when you familiarise a new compound, safety is very essential,” Fauci said, noting that vaccines persist “our best tackles against Covid-19” by averting contagion and illness, rather!