Pfizer’s (NYSE:PFE) Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) became the first oral SARS-CoV-2 antiviral to win emergency use authorization (EUA).
The EUA covers the use of the drug to treat mild-to-moderate COVID-19 in patients who are at least 12 and weighing at least 40 kg (88 pounds).
The agency has yet to officially weigh in on molnupiravir, an oral antiviral from Merck and Ridgeback Biotherapeutics that has won approval in the U.K. In late November, an FDA advisory committee narrowly blacked that drug.
FDA’s authorization of Paxlovid requires a prescription. The agency recommends using the drug as soon as possible after a positive COVID-19 test result, specifying it should not be used five days after symptoms develop.
The authorization does not cover the use of the drug as pre-exposure or post-exposure prophylaxis.
“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 Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a statement.
FDA also stressed that Paxlovid is not intended to be used as a substitute for COVID-19 vaccination.