The Food and Drug Administration Thursday issued an emergency use authorization for another COVID-19 pill. Merck’s molnupiravir may now be used to treat mild-to-moderate symptoms of the disease in high-risk patients who are 18 years or older.
Molnupiravir is not authorized for patients younger than 18 because it may affect bone and cartilage growth, the FDA says.
“Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally. 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,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “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.”
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Molnupiravir is a medication that works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from further replicating. Clinical trials indicate the drug may cause harm to fetuses, so, it is not recommended for women who are pregnant.
Merck’s EUA comes one day after the FDA approved the nation’s first COVID treatment pill. The federal health agency granted emergency use of Pfizer’s Paxlovid for patients 12 years and up.
Paxlovid is a 5-day, 30 pill treatment and molnupiravir is a 5-day, 40 pill treatment. Both drugs are available only with a prescription.
According to FDA guidance, both therapies should be initiated as soon as possible after diagnosis and within five days of symptom onset to reduce the severity of COVID-19.
Health officials stress the pills are not a substitute for vaccinations and boosters.
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