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Pfizer seeks full FDA approval for COVID-19 antiviral Paxlovid 

By Brian Buntz | June 30, 2022

PfizerPfizer Inc. (NYSE:PFE) has filed a new drug application (NDA) with the FDA for approval of Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for individuals facing a high-risk for progression to severe illness from COVID-19.

Paxlovid consists of the SARS-CoV-2 main protease inhibitor nirmatrelvir (PF-07321332) and  the HIV-1 protease inhibitor and CYP3A inhibitor ritonavir. Because ritonavir blocks the liver enzyme CYP3A related to drug metabolism, its use reduces the effective dose of nirmatrelvir.

The approval, if granted, would cover the use of the antiviral in vaccinated and unvaccinated individuals deemed to have a high risk of progression to severe COVID-19.

The EUA for Paxlovid currently covers the treatment of mild-to-moderate COVID-19 in high-risk individuals at least 12 years old who weigh at least 40 kg. The EUA requires a positive test result and that recipients.

The drug is not authorized for use for more than 5 consecutive days.

Pfizer’s placebo-controlled Phase 2/3 EPIC-HR study (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) concluded that Paxlovid led to an 86% reduced relative risk of hospitalization or death from any cause through week 24.

At least half of the U.S. public is believed to have at least one risk factor for severe COVID-19.


Filed Under: clinical trials, Drug Discovery, Infectious Disease
Tagged With: Paxlovid, Pfizer
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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