Pharma Focus Asia

Pfizer Announces FDA Approval of PAXLOVID™ for Adult Patients

Friday, May 26, 2023

Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalisation or death.

PAXLOVID is currently approved or authorised for conditional or emergency use in more than 70 countries across the globe to treat COVID-19 patients having increased risk for progressing to severe illness.

This approval marks a monumental milestone as PAXLOVID became the first COVID-19 oral treatment to be approved by the U.S. FDA, to bring its value to patients, providers, and health systems.

The FDA approval of PAXLOVID is based on the totality of scientific evidence shared by Pfizer, including safety and efficacy data from the EPIC (Evaluation of Protease Inhibition for COVID-19) clinical development programme. The data showed an 86 percent reduction in risk of COVID-19-related hospitalisation or death from any cause through Day 28 in patients who initiated treatment with PAXLOVID within five days of symptoms onset, compared to placebo.

PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It is developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalisation and death).
 

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