Vaccines will be the way out of the pandemic, but not everyone in the world is vaccinated yet, and vaccinations don’t 100% protect people from contracting the COVID-19 virus. Therefore, antiviral drug treatments will be key to ensuring that people who do become infected do not become seriously ill.
Merck announced Encouraging results are provided by a study on its COVID-19 antiviral drug molnupiravir. In an early look at the data from a Phase 3 study, the company said the drug reduced the risk of hospitalization or death for people taking the pills by 50% compared to people not taking the drug, after developing mild to moderate COVID-19. Twenty-nine days after taking the drug or placebo, 7.3% of patients receiving molnupiravir were hospitalized or died compared with 14.1% of patients receiving placebo.
The drug is the first oral antiviral for COVID-19 and is slated to be prescribed to people who develop symptoms of COVID-19 but are not sick enough to be hospitalized. Remdesivir, the first drug approved by the U.S. Food and Drug Administration (FDA) to treat the disease, is intended for people hospitalized with COVID-19 and must be given intravenously. The other three antiviral drugs that have received EUA are also given via IV.
Due to the strongly positive results, Merck terminated the study prematurely, as the drug shows a clear benefit. Merck will shortly file an EUA application for the drug with the FDA and other regulatory agencies around the world.
The analysis included 775 patients from study centers around the world who took the pill or placebo twice a day for five days. Molnupiravir works by preventing SARS-CoV-2 from copying its genetic material, which it has to do to infect more cells. Because it likely targets the basic mechanisms that the virus relies on to replicate, rather than the parts that mutate into new variants, the early preclinical and human studies also showed that the drug was effective against different variants of the virus is.
According to a company release, Merck has already made molnupiravir in the hopes that the Phase 3 study would show that it is both safe and effective. The company has already agreed to provide 1.7 million doses of molnupiravir to the US government, subject to FDA approval. In addition, Merck has licensing agreements with generic drug companies to manufacture the drug in more than 100 low- and middle-income countries if approved there.
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