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
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