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Pfizer Submits NDA For PAXLOVID To FDA To Treat Severe Illness From COVID-19

Pfizer Inc. (PFE) announced Thursday the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for both vaccinated and unvaccinated patients who are at high risk for progression to severe illness from COVID-19.

PAXLOVID is currently authorized for emergency use for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

The submission provides the longer-term follow-up data necessary for acceptance and potential approval.

According to the U.S. Centers for Disease Control and Prevention (CDC), 50-60% of the U.S. population is estimated to have one or more risk factors for progressing to severe COVID-19 illness.

The NDA submission is supported by non-clinical and clinical data for PAXLOVID. It includes results from the Phase 2/3 EPIC-HR study (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients), which found that, compared to placebo, treatment with PAXLOVID reduced the risk of hospitalization or death from any cause by 88% in non-hospitalized, high-risk adult patients treated within five days of symptom onset.

The final results from EPIC-HR study showed an 86% reduction in relative risk of hospitalizations or death from any cause and no deaths were observed in patients treated with PAXLOVID through Week 24, compared to 15 deaths observed with placebo.

PAXLOVID is currently approved or authorized for conditional or emergency use in more than 65 countries across the globe to treat COVID-19 patients who are at increased risk for progressing to severe illness.

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