The Food and Drug Administration on Thursday issued an emergency use authorization for Merck’s molnupiravir COVID-19 pill, making it the second oral antiviral treatment available in the U.S. to treat the viral infection.
Officials authorized the pill to treat mild-to-moderate COVID-19 in adults who have tested positive for the viral infection, who are at high risk for progression to severe illness from the virus and for whom other COVID-19 treatment options are not accessible or clinically appropriate.
The pill was not authorized to treat people younger than 18 because of concerns over its possible impact on bone and cartilage growth.
“Molnupiravir ... will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said Thursday in a statement. “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.”
Late last month, an FDA committee narrowly voted to endorse making molnupiravir available by prescription, though some committee members expressed concerns over the potential impact on people who are of childbearing age. Animal studies have showed molnupiravir has the potential to negatively impact bone development in fetuses. Committee members also questioned the possibility that the drug could drive mutations of the virus.
In November, officials with Merck reported final study results which showed that molnupiravir reduced the risk of hospitalization and death among people who took the pill when compared to those taking a placebo by 30%. That same month, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency authorized molnupiravir for treatment of people with mild to moderate COVID-19 who have at least one risk factor for developing severe illness. Agency officials pointed to clinical data which showed the drug, which interferes with the replication of the virus, was “safe and effective at reducing the risk of (hospitalization) and death.”
On Thursday, officials with the FDA said in a statement that molnupiravir “is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.”
“The FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes associated with a COVID-19 infection, including hospitalization and death,” the statement said. “The FDA urges the public to get vaccinated and receive a booster if eligible.”
As of Wednesday morning, nearly 73% of the U.S. population – 241.5 million people – has gotten at least one dose of any of the available COVID-19 vaccines, according to the Centers for Disease Control and Prevention. Almost 62% of Americans, or 204.8 million people, have been fully vaccinated, and nearly 31% of those who have been fully vaccinated have gotten booster shots, CDC data shows.
Since the start of the pandemic, officials have reported 51.5 million cases of COVID-19 nationwide, resulting in more than 812,000 deaths, according to a tally from Johns Hopkins University. Globally, 277.2 million cases have been reported, resulting in 5.3 million deaths, according to the university.
Regulators authorized molnupiravir one day after issuing emergency use authorization for Pfizer’s COVID-19 pill, Paxlovid, for treatment of mild-to-moderate COVID-19 in people aged 12 and older.
©2021 Cox Media Group