The U.S. Food and Drug Administration (FDA) on May 25 fully approved Pfizer’s oral antiviral medication Paxlovid to treat mild to moderate COVID-19 in adults at risk of severe infections.
This clears the way for the drugmaker to sell it at market rates once the U.S. government supplies dwindle.
The FDA says that Paxlovid is the fourth drug and first antiviral pill to be approved for the treatment of COVID-19. The drug is a combination of two medications—nirmatrelvir and ritonavir—which are taken together as pills within the first five days of a person’s COVID-19 symptoms.
Nirmatrelvir and ritonavir tablets had been available for adults and teens in the United States in late 2021 under an emergency use authorization (EUA), which strictly limited how the medication could be prescribed. The FDA’s standards for full approval are stricter than those for an EUA.
“Today’s approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a news release.
The full approval comes two weeks after the United States ended the public health emergency status for COVID-19, which the government estimates has caused about 1.1 million deaths nationwide.
However, the approval covers only treatment for adults, but the FDA says the drug will still be available for adolescents aged 12 to 18 under EUA. It is currently not authorized for use as a pre-exposure or post-exposure prophylaxis for the prevention of a COVID-19 infection.
It is difficult for some people to take because it has interactions with many other types of medications. For that reason, it will come with a black box warning about its potential to interfere with other drugs.
The federal agency plans to work through much of the Paxlovid inventory purchased from Pfizer, which is available for free at pharmacies around the country, before moving to a normal commercial market. Pfizer said in a statement that at this time, the government will continue to oversee distribution and eligible residents will continue to receive it at no charge.
The FDA also added that based on data currently available, there has been no association between nirmatrelvir and ritonavir tablets and COVID-19 rebound.
As of May 21, around 14 million treatment courses had been distributed of which over 9 million had been administered, according to federal data. Pfizer has sold the U.S. government nearly 24 million courses of Paxlovid at around $530 a course.
The Institute for Clinical and Economic Review, an influential drug pricing research group, said in December the U.S. price for Paxlovid should be in the range of $563 to $906 per treatment course.
Pfizer received a once-in-a-lifetime cash windfall from sales of its COVID-19 vaccine and treatment. It sold around $18.9 billion of Paxlovid last year and has forecast sales of about $8 billion for 2023.
Paxlovid is currently authorized for conditional or emergency use in more than 70 countries across the globe to treat COVID-19 patients who are at increased risk for progressing to severe illness, according to Pfizer.