Patients will need a prescription and should start taking the pill within five days of experiencing symptoms. The treatment is taken twice a day for five days.
Clinical trials showed that Merck’s pill reduced the risk of hospitalization and death from the virus by 30 percent.
“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,” said Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research.
The FDA on Wednesday authorized the country’s first antiviral pill for Covid — Pfizer’s Paxlovid — which the agency said should be an important tool for helping reduce the current strain on hospitals flooded with Covid patients and grappling with health worker shortages. In clinical trials, Pfizer’s treatment reduced the risk of hospitalization and death by 89 percent when taken three days after the onset of symptoms.
On a press call Thursday, top FDA officials said that the Merck drug, whose effectiveness is significantly lower than Pfizer’s, is recommended for patients for whom other treatments are not available.
But they insisted that doctors should decide which pill to prescribe on a case by case basis, noting that Pfizer’s drug could interact badly with some other medications and isn’t safe for people with severe liver or kidney disease.
For both drugs, stressed John Farley, the director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, “their known and potential benefits outweigh their known and potential risks.”
The authorizations come as Omicron has been detected in all 50 states, leading to a surge in new infections. More than 60,000 Americans are currently hospitalized with Covid-19, according to the Centers for Disease Control and Prevention, and the country is recording more than 160,000 new infections every day.
The authorizations come as Omicron has been detected in all 50 states, leading to a surge in new infections. More than 60,000 Americans are currently hospitalized with Covid-19, according to the Centers for Disease Control and Prevention, and the country is recording more than 160,000 new infections every day.
These pills, which can be taken at home, are expected to reach far more people than monoclonal antibody drugs, which are typically infused in a clinical setting, and had, until this week, been the only authorized treatment for Covid-19 patients who are not hospitalized.
The Biden administration has already purchased 3.1 million courses of molnupiravir and 10 million courses of Paxlovid.
Katherine Ellen Foley contributed to this report.
