What is molnupiravir and how does it fight covid-19?
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(CNN) -
Merck reported on Monday that it has applied to the US Food and Drug Administration (FDA) for an emergency use authorization for its experimental antiviral treatment against covid-19, molnupiravir.
If authorization is granted, the drug, made by Merck and Ridgeback Biotherapeutics, would be the first oral antiviral treatment to combat COVID-19.
It comes in capsule form.
Merck has said it is requesting authorization for the capsules to treat infected adults who are at risk of progressing to severe COVID-19 disease or being hospitalized.
His presentation is based on a study that stopped midway because the drug was working so well in more than 700 patients randomly assigned to take molnupiravir or a placebo.
"In the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%. 7.3% of patients who received molnupiravir were hospitalized or died by day 29 after randomization, compared to day 14, 1% of patients treated with placebo, "the company said in a statement.
What is molnupiravir and how does it fight covid-19?
3:53
"As of day 29, there were no deaths in the patients who received molnupiravir, compared with eight deaths in the patients who received placebo."
None of the trial volunteers had been vaccinated.
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"The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data," said the Merck CEO and President Robert Davis in the statement.
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The trial data have not yet been reviewed or published.
"Merck has been producing molnupiravir at risk and expects to produce 10 million treatments by the end of 2021, with more courses expected to be produced in 2022," the company said.
It has already sold 1.7 million of treatment to the US government.
The company said it will offer tiered pricing to facilitate access worldwide, and will work with generic drug manufacturers to accelerate availability in low- and middle-income countries.
At a covid-19 briefing at the White House, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the trial results "very encouraging," but said the drug should be closely examined. by the FDA.
"It is very important that this now goes through the usual process of close scrutiny of the data by the Food and Drug Administration, both in terms of efficacy and safety, because whenever a new compound is introduced, safety is very important, "said Fauci, noting that vaccines remain" our best tools against covid-19 "by preventing infection and disease, rather than treating it.
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