The U.S. Food and Drug Administration granted full approval to Pfizer’s (PFE.N) oral antiviral COVID-19 treatment Paxlovid.
Clearing the way for the drugmaker to sell it at market rates once U.S. government supplies dwindle.
Paxlovid initially received emergency use authorization from the FDA in late 2021, when there was a desperate need for effective COVID treatments. The agency on Thursday approved the two-drug therapy to treat adults at high risk of progression to severe disease.
Paxlovid, taken for five days beginning shortly after the onset of symptoms, was one of the few treatments launched by drugmakers during the pandemic to show a significant reduction in hospitalizations and deaths from COVID, although the benefit was mostly observed in unvaccinated and other higher-risk people.
U.S. officials have said they plan 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.
As of May 21, around 14 million treatment courses had been distributed of which over 9 million had been administered, according to federal data.
A Pfizer spokesperson said the company does not plan to provide a new price for Paxlovid. The U.S. drugmaker 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. Full approval allows Pfizer to expand its Paxlovid marketing campaign.
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 (ICER), an influential drug pricing research group, said in December the U.S. price for Paxlovid – based on the benefits and value to patients – 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 vaccine and treatment. It sold around $18.9 billion of Paxlovid last year and has forecast sales of about $8 billion for 2023.
The full approval comes two weeks after the U.S. ended the public health emergency status for COVID-19, which has caused about 1.1 million deaths nationwide, according to government estimates.
Data presented by both the FDA and Pfizer during an advisory meeting of outside experts helped ease safety concerns around a potential rebound in COVID symptoms after a five-day Paxlovid course.
The concerns emerged after numerous reports about a return of symptoms following treatment with Paxlovid, including in high-profile patients such as President Joe Biden and Dr Anthony Fauci.