FDA Grants Full Approval to Pfizer’s Paxlovid

26.05.2023 - Pfizer's oral anti-viral Covid-19 treatment Paxlovid has won full approval from the US Food and Drug Administration (FDA) after Emergency Use Authorization was granted in late 2021.

Paxlovid is the fourth drug, and the first oral antiviral, approved by the FDA to treat infection with the deadly coronavirus variant in adults.

Specifically, the two-drug therapy, which earned $19 billion for the US pharma giant last year, was authorized to treat mild-to-moderate Covid infections in adults at a high risk of progression to severe disease. 

Full approval means that Pfizer can charge the full commercial price for Paxloid when US government's supplies are depleted. However, the FDA said supplies manufactured and packaged under the EUA and distributed by the US Department of Health and Human Services will continue to be available to patients not covered by the final approval.

Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of Covid-19, the agency stressed.

The drug regulator said efficacy of the Covid treatment cocktail was primarily supported by the final results of the EPIC-HR clinical trial. The randomized, double-blind, placebo-controlled study evaluated Paxlovid for treatment of non-hospitalized symptomatic adults with a laboratory confirmed diagnosis of SARS-CoV-2 infection.

Author: Dede Williams, Freelance Journalist