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On Thursday, Dec. 23, the FDA approved the use of Merck’s molnupiravir pill for emergency use authorization, a day after officials authorized the use of Pfizer’s COVID-19 treatment pill.
Merck’s pill has been cleared for use by adults 18 and older who have tested positive for COVID-19 and are at the greatest risk of being hospitalized or dying from the virus.
According to the FDA, molnupiravir is available by prescription only and should be initiated as soon as possible after a diagnosis of COVID-19 and within five days of the onset of symptoms.
"Of the 709 people who received molnupiravir, 6.8 percent were hospitalized or died within this time period compared to 9.7 percent of the 699 people who received a placebo," officials said. "Of the people who received molnupiravir one died during the follow-up period compared to nine people who received placebo.”
Diarrhea, nausea, and dizziness were among the side effects reported by subjects during the trial.
“Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally,” Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research stated. “Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death.
“As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness.”
Officials noted that molnupiravir is not authorized for use in patients younger than 18 years of age because it may affect bone and cartilage growth. It is also not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in patients hospitalized due to the virus.
"The FDA Emergency Use Authorization of molnupiravir is an important milestone in the fight against COVID-19, and adds to Merck’s legacy of bringing forward innovative medicines that both address the world’s greatest health threats and help save lives," Merck CEO and President Robert Davis said in a statement.
"Because we recognized the promise of molnupiravir early, Merck invested at risk and we are executing an unprecedented global access strategy so that molnupiravir, now authorized, can be available to patients here in the US and all around the world more quickly and more equitably than has ever been accomplished before,”
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