Positive COVID Test Result No Longer Required to Prescribe Paxlovid, Lagevrio: FDA

Doctors and pharmacists are now able to prescribe COVID-19 drugs Paxlovid Lagevrio to patients with a negative test for infection, the U.S. Food and Drug AdministrationFDAWednesday

Pfizer’s Paxlovid and Merck’s Lagevrio were granted emergency-use authorizations by the FDA in December 2021. Since then, both oral pills have been used postinfectionally for patients with mild-to-moderate symptoms of COVID.

The FDA stated in the revised authorizations that health professionals may be authorized to use the new authorizations. “no longer require positive results of direct SARS-CoV-2 viral testing” Before providing the drugs to patients. Instead, authorizations require that all adults and children 12 years old and older have an authorization. “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,” In a statement, the FDA stated.

“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 was 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 The company also projected 2022 earnings and 2023 forecasts. It stated that there would likely be a 64% drop in 2023 revenue from COVID vaccines. The company also predicts that Paxlovid’s revenue will drop by 58 per cent.

Pfizer expects its 2023 revenue to drop between $67 billion-$71 billion due to the declines. New York City’s company reported a revenue of 100.3 billion in 2022.

Pfizer expects Paxlovid to be sold for $8 billion by 2023. Pfizer claimed that it made more than $18.9billion from the postinfection drug between 2022 and 2023.

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, Beijing offered a price that was lower than what Pfizer executives would accept as a starting price. “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,” Albert Bourla is the chief executive of Pfizer. reported Reuters.