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The full approval for the antiviral drug to treat adults at high risk of progression to severe disease will also help the company expand its marketing campaign.
U.S. officials have said they plan to work through much of the inventory of Paxlovid bought from Pfizer, which is available for free at pharmacies around the country, before moving to a normal commercial market for the drug.
Pfizer has sold the U.S. government nearly 24 million courses of Paxlovid at around $530 a course. It is not clear yet what the commercial price will be for the drug.
As of May 21, around 14 million courses had been distributed and more than 9 million courses of the drug had been administered, according to federal data.
The approval shows that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, said FDA’s Patrizia Cavazzoni, adding that it remains an important treatment option for people at high risk of progression to severe COVID-19.
The green light comes nearly six months after the health regulator extended the review period for the drug and is in line with the recommendation earlier this year by a panel of advisers who voted in favor of granting full approval.
The pill was initially authorized in late 2021 for emergency use in the U.S. Sales are expected to significantly drop this year.
Data presented by both the FDA and Pfizer during the advisory meeting in March helped ease safety concerns around a potential rebound in COVID-19 symptoms after a five-day Paxlovid course.
