WASHINGTON — The U.S. Food and Drug Administration approved XOCOVA, the first and only oral medication to prevent COVID-19 after exposure to the virus, for people ages 12 and older. The approval establishes a new preventive treatment option for individuals who have been in close contact with someone infected with SARS-CoV-2.
XOCOVA is administered as a five-day pill regimen. Patients take three tablets on the first day of treatment and one tablet per day on days two through five. The drug works by blocking viral replication before symptoms develop, according to drug maker Shionogi.
In clinical trials, XOCOVA reduced the risk of developing symptomatic COVID-19 by 67% compared to a placebo. The medication is intended for use shortly after known exposure to the virus and before the onset of symptoms.
Common side effects reported during trials include headache, diarrhea, and cough. The FDA’s approval covers individuals weighing at least 40 kilograms (about 88 pounds) and aged 12 years or older.
The approval follows the ongoing public health impact of the pandemic. About 1.2 million people in the U.S. are believed to have died from COVID-19 between 2019 and June 1, 2024, according to the U.S. Centers for Disease Control and Prevention.