Older Americans suffering from COVID-19 who are at risk of severe outcomes now can take medication at home to treat the illness. The Food and Drug Administration today issued emergency use authorization for Paxlovid, the first COVID-19 pill available in the United States.
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
A pill from Merck also is expected to receive FDA authorization this week. Paxlovid is believed to be the preferred drug, in part, because it cuts the rate of hospitalization and death from COVID-19 by nearly 90%.
Regulators approved Paxlovid for children ages 12 years and older with positive COVID-19 tests and early symptoms who are most likely to be hospitalized. This includes older adults and people with conditions such as obesity and heart disease.
The approval of this drug is significant because of its convenience. Other COVID-19 treatments are available, but administering these drugs is much more difficult. For example, remdesivir is approved only for hospitalized patients and must be taken intravenously. Monoclonal antibody treatments, which are available to nonhospitalized, at-risk adults to fend off severe outcomes, also must be delivered intravenously or through injection.
Still, people who want to take the pill need a positive COVID-19 test to receive a prescription. It also must be taken within five days of symptoms appearing for it to be effective. The treatment entails taking three pills twice a day for five days.
The U.S. government has planned to purchase enough Paxlovid to treat 10 million people.
