The Slatest

Merck Seeks FDA Approval for First Antiviral COVID-19 Pill

Employees walk past a Merck sign in front of the company's building on October 2, 2013 in Summit, New Jersey.
Employees walk past a Merck sign in front of the company’s building on October 2, 2013 in Summit, New Jersey. Kena Betancur/Getty Images

Merck is seeking Food and Drug Administration emergency use authorization to become the first pharmaceutical company to put an antiviral COVID-19 pill on the market. The drug, produced in conjunction with Ridgeback Biotherapeutics, could prove to be a game changer in the pandemic as it would provide the first treatment that people could take at home before they are severely ill. Early results on the experimental drug, molnupiravir, show that mild-to-moderately ill patients with at least one risk factor who take it within five days of COVID-19 symptoms had about half the rate of hospitalization than those who received a placebo.

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The preliminary study followed 775 patients with mild-to-moderate COVID-19 who had a risk factors, such as obesity or diabetes, that put them at high risk of developing severe disease. Among those who took molnupiravir, 7.3 percent were hospitalized compared with 14.1 percent of those who received a placebo. While there were no deaths among those who took the drug, eight died in the placebo group. The results of the study, which have not been peer-reviewed nor published, were so strong that it was stopped early.

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For now, the only drugs that are being used to treat COVID-19 patients in the United States require an IV or an injection and are largely supplied in a hospital setting. A pill that could be taken at home could help ease pressure on hospitals as well as help people in remote areas and poorer countries that may not have access to the more expensive drugs. The treatment plan currently calls for patients to take four pills of molnupiravir twice a day for five days. The company has a contract with the U.S. government to supply enough treatment for 1.7 million people at $700 each once the FDA approves the drug. Merck has said it can produce pills for 10 million patients by the end of the year and will license the pill to several generic drugmakers in India to supply low- and middle-income countries.

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Experts caution that the pill shouldn’t be seen as a replacement for vaccination but rather a complement. Although Merck only studied the effect of the drug on people who weren’t vaccinated, there’s a possibility the FDA will also authorize the treatment for people who are vaccinated and get a breakthrough infection. The White House has made clear that even if approved, the strategy will continue to be to push for vaccination as the main way to control the pandemic. “We want to prevent infections, not just wait to treat them when they happen,” White House coronavirus coordinator Jeff Zients said.

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