Doctors and pharmacists can now prescribe COVID-19 drugs Paxlovid and Lagevrio to patients without a positive test of infection, the U.S. Food and Drug Administration (FDA) said Wednesday.
Pfizer’s Paxlovid and Merck’s Lagevrio were granted emergency-use authorizations by the FDA in December 2021. Both oral pills have since been used as postinfection treatments for patients experiencing mild-to-moderate COVID symptoms.
In the revised authorizations, the FDA wrote that health professionals may “no longer require positive results of direct SARS-CoV-2 viral testing” before providing patients with the two drugs. Instead, the authorizations now require that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”
“The agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19,” the FDA said in a statement.
“We recognize that, in rare instances, individuals with a recent known exposure (e.g. a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their health care provider as having COVID-19 even if they have a negative direct SARS-CoV-2 test result,” the federal agency added. “In such instances, their health care provider may determine that treatment with authorized therapeutics may be appropriate if the patient reports mild-to-moderate symptoms of COVID-19 and is at high risk for progression to severe COVID-19.”
The relaxation on Paxlovid’s pharmacy access comes as Pfizer anticipates significant drops in revenue, largely due to a decline in sales of COVID-19 products.
In a report detailing its fourth quarter and 2022 full-year earnings and 2023 expectations, the company told investors there will likely be a 64 percent drop in 2023 in revenue generated by selling COVID vaccines. It also projects that the revenue from Paxlovid will decrease by 58 percent.
With the decreases, Pfizer is expecting its 2023 revenue to fall in a range between $67 billion and $71 billion. The New York City company reported a revenue of $100.3 billion in 2022.
For Paxlovid, Pfizer predicts sales of $8 billion in 2023. Pfizer said it made over $18.9 billion from the postinfection drug in 2022.
In January, following an unsuccessful negotiation between Beijing and Pfizer, China’s National Healthcare Security Administration said it won’t include Paxlovid in its national reimbursement plan.
According to reports, the price proposed by Beijing was less than Pfizer executives would accept from a “middle-income country.”
“China is the world’s second-largest economy, and I don’t think it should pay less than El Salvador, which is a poor country,” said Pfizer chief executive Albert Bourla, reported Reuters.