Merck applied on October 11, 2021, for the FDA to authorize its antiviral pill to treat COVID-19, a first of its kind in this pandemic.
So far, all FDA-backed treatments for coronavirus require at least an injection to administer, if not an IV. This means they can’t be done at home, but must be given to patients by healthcare staff even in cases that don’t merit hospitalization. An antiviral pill could be taken at home by a symptomatic patient, relieving the burden on hospitals and clinics, curbing symptoms, and making a patient less contagious.
Specifically what Merck is asking for is emergency use authorization for the drug to be used to treat adults with mild-to-moderate COVID-19, who are at risk for severe disease, long-term symptoms, or hospitalization. This is the same authorization that the injectable antiviral treatments have been given.
According to the company, trial use of the pill cut both hospitalizations and deaths by half among patients with early symptoms of COVID-19. Side effects were similar between patients who received the drug and those in the control group who were given a placebo treatment. The FDA has been given a full report on the trial study, including all negative and positive results and potential side effects.
“The value here is that it’s a pill so you don’t have to deal with the infusion centers and all the factors around that,” said Dr. Nicholas Kartsonis, a senior vice president in Merck’s infectious disease unit. “I think it’s a very powerful tool to add to the toolbox.”
News articles have compared this pill to Tamiflu, the effective medication that shortens and softens cases of influenza and has been in widespread use for 20 years. If the drug receives its authorization, the U.S. government has agreed to buy enough of the medication to treat 1.7 million people for approximately $1.2 billion. That works out to roughly $700 per course of treatment, which while more expensive than any other antiviral pill for any other condition, is less than half the cost of any of the injectable treatments for COVID-19.
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