Pharmaceuticals Merck announced today that it will ask the US regulator to authorize the emergency use of a drug to treat people infected with SARS-CoV-2, following the results of trials with patients with covid-19.
According to the company, which also intends to proceed with the authorization request to other regulatory entities, the phase three tests with this oral antiviral – molnupiravir – halved hospitalizations and deaths in infected people with mild symptoms.
If approved, the drug will be the first pill to treat covid-19, since, so far, all authorized therapies require intravenous intervention in a hospital setting.
Merck and Ridgeback Biotherapeutics added that the first results showed that in the group of patients who received molnupiravir for five days after symptoms, there was a rate of hospitalization and death of about d. and half compared to the group given a placebo.
The study followed 775 adults with covid-19 with mild to moderate symptoms and who were considered at higher risk for severe disease due to health problems such as obesity, diabetes or heart disease.
Among patients taking molnupiravir, 7.3% were hospitalized or died at the end of 30 days, compared with 14.1 % of those who took the placebo, says the Associated Press agency.
An independent group of experts who monitored the study recommended its early interruption due to the results obtained, a procedure that happens when the data demonstrate that a treatment works and that, therefore, there is no need for further tests before requesting authorization.
The responsible of the laboratories also said that they intend to send the data to the North regulator. American (FDA) in the coming days, which may make a decision within a period of time. s weeks.
“It exceeded what I thought the drug might be able to do in this clinical trial,” said Dean Li, vice president of Merck Research Laboratories, who says a reduction in 50% of hospitalizations and deaths “is a substantial clinical impact.”
The Merck tablet, twice daily for five days, interferes with the coronavirus’s ability to copy its genetic code and to reproduce.
The US government has already committed to purchase 1.7 million doses of the drug, if authorized by the FDA, and Merck has said that it can produce 10 million doses up to the end of the year.
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