U.S. Food and Drug Administration officials on Thursday approved emergency use of an oral drug developed by Emory University researchers to treat COVID-19 patients, including those with severe symptoms.
The drug, molnupiravir, is for people with mild-to-moderate symptoms who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative treatment options authorized by the FDA are not accessible or clinically appropriate.
“(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 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.”
Merck anticipates it will begin shipping molnupiravir to its distributor within days. Trial research of the drug was conducted before the recent discovery of the omicron variant. FDA officials, though, told reporters Thursday that preliminary data shows molnupiravir is effective against the variant. Merck has agreed to supply approximately 3.1 million courses of molnupiravir to the federal government.
Molnupiravir is the second drug to receive emergency use authorization for COVID-19 treatment. On Wednesday, the FDA approved emergency use of Pfizer’s paxlovid.
Molnupiravir is available by prescription only. It is not authorized for use in patients younger than 18 and not recommended for pregnant women because of potential side effects.
There are some questions about its effectiveness. While Britain last month became the first country to approve molnupiravir, France canceled its order for the drug upon reviewing trial data that raised concerns among some medical leaders. While it reduces the risk of hospitalization and death among high-risk patients by 30%, that is less than authorized antibody treatments, which have been shown to reduce the risk of severe outcomes by about 70%. An FDA advisory panel voted 13-10 on Nov. 30 in favor of emergency use authorization.
Side effects observed in trial research included diarrhea, nausea and dizziness. Researchers said it might affect bone and cartilage growth in those under 18.
It is not authorized for preexposure prevention of COVID-19 or for initiation of treatment in patients hospitalized because benefit of treatment has not been observed in people when treatment started after hospitalization.
Molnupiravir is designed to prevent the virus from further replicating. It should be administered as four 200-milligram capsules taken orally every 12 hours for five days. Molnupiravir is not authorized for use for longer than five consecutive days.
Credit: Emory (contributed
Credit: Emory (contributed
Emory has called the drug “the little pill that could.”
Emory University’s Drug Innovation Ventures, also known as DRIVE, licensed the medication last year to Merck pharmaceutical company through its partner Ridgeback Biotherapeutics.
In 2013, the Emory team began work that could attack many viruses. It showed strong results in animal testing against coronaviruses, including SARS, and the Middle East respiratory syndrome (MERS). Last year, as the coronavirus pandemic surfaced, the DRIVE team worked with researchers at Vanderbilt and Georgia State University for more testing.
“This drug is a direct intervention at a time when this pandemic is not yet over,” said George Painter, DRIVE’s CEO and director of the Emory Institute for Drug Development. “When you look at the daily death toll, and you think that this can help — it doesn’t require enormous medical infrastructure to give, can be distributed easily and self-administered — you begin to think about the impact and all that could have. It’s overwhelming.”
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