FDA authorizes Merck’s Covid-19 pill


The Food and Drug Administration on Thursday authorized a second antiviral pill for people infected with Covid as the Biden administration works to ease the burden on hospitals swamped with patients during this most recent surge.

The agency is only authorizing Merck’s pill, called molnupiravir, for people who test positive, are at high risk for severe disease and are at least 18 years old. FDA said Thursday that the pill can’t be used by patients younger than 18 because it “may affect bone and cartilage growth.”

The agency also warned against its use for pregnant patients, noting that animal studies found it could cause “fetal harm,” but said individual physicians could weigh the risks and benefits and prescribe it to a pregnant person who is at high risk of severe Covid.

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.

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.

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