U.S. pharmaceutical company Merck to seek approval for world’s first oral antiviral drug for COVID-19 soon
U.S. pharmaceutical company Merck & co said on Friday that its experimental COVID-19 pill was halving hospitalizations and deaths among people recently infected with the coronavirus. If cleared by U.S. health officials, it would be the first pill to treat COVID-19 – a potentially major breakthrough in efforts to fight the pandemic. Molnupiravir is now set to become the first oral antiviral drug for COVID-19.
“In the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%. patients (53/377); p = 0.0012. Up to day 29, no deaths were reported in patients who received molnupiravir, compared to 8 deaths in patients who received placebo, “reads an excerpt from data published by Merck and its partner Ridgeback. .
The study followed 775 adults with mild to moderate COVID-19 who were considered to be at higher risk of serious illness due to health conditions such as obesity, diabetes or heart disease. Results from previous studies showed that the drug did not benefit patients who were already hospitalized with serious illness.
“Eligibility criteria required that all patients have mild to moderate laboratory-confirmed COVID-19, with onset of symptoms within 5 days of study randomization. All patients had to have at least one factor. risk associated with poor disease outcome upon entry into the study, “the company said.
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An independent group of medical experts overseeing the trial recommended stopping it early because the intermediate results were so strong. Although both groups reported unspecified side effects, they were slightly more common in the group given the dummy pill. According to reports citing business executives, they were in discussions with the United States Food and Drug Administration. The results have been published by the company and have not been peer reviewed. Merck plans to submit the data for review in the coming days.
In anticipation of the MOVe-OUT results, Merck is producing unsafe molnupiravir. Merck plans to produce 10 million treatments by the end of 2021, with more doses expected to be produced in 2022. Earlier this year, Merck entered into a supply agreement with the US government under which Merck will supply approximately 1 , 7 million treatments of molnupiravir. to the US government, with authorization from the EUA or US FDA.
In addition, Merck has entered into supply and purchase agreements for molnupiravir with other governments around the world, pending regulatory approval, and is currently in discussions with other governments.
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Posted on: Friday October 01, 2021, 5:58 PM IST