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Pfizer Reports NDA Submission of Paxlovid to the US FDA for the Treatment of COVID-19

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Pfizer Reports NDA Submission of Paxlovid to the US FDA for the Treatment of COVID-19

Pfizer Reports NDA Submission of Paxlovid to the US FDA for the Treatment of COVID-19

Shots:

  • The NDA was submitted based on the P-II/III (EPIC-HR) & (EPIC-SR) trial evaluating Paxlovid (nirmatrelvir + ritonavir, n=1400 & 361) vs PBO (n=1406 & 360) in patients with high/standard risk COVID-19
  • The results demonstrated an 86% & 57% reduction in hospitalization/death vs 15 deaths in PBO @28days whereas the data from the EPIC clinical development program incl. (EPIC-HR), (EPIC-SR) & (EPIC-PEP) studies showed a reduction in viral load in delta/omicron variants & consistent safety in patients (n=3500) treated with Paxlovid
  • Paxlovid (300 & 100mg) is an oral SARS-CoV-2 Mpro inhibitor of viral replication at the proteolysis stage & has been approved for conditional/emergency use across 65 countries

Ref: Businesswire | Image: Pfizer

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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