Pfizer Receives the US FDA Emergency Use Authorization for Paxlovid to Treat Mild-to-Moderate COVID-19 in Adults and Pediatric Patients
Shots:
- Pfizer announced the US FDA has authorized the emergency use of Paxlovid (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing, and at high risk for severe COVID-19 progression
- The EUA is based on clinical data from EPIC-HR study which showed that Paxlovid reduced risk of hospitalization or death by 89% (within 3 days of symptom onset) and 88% (within 5 days of symptom onset) vs. PBO
- The company is planning to file an NDA with the FDA for full regulatory approval in 2022. Additionally, Pfizer will start the immediate delivery in the US, in line with its agreement with the US govt to supply 10M treatment courses between 2021 and 2022
Ref: Pfizer | Image: Pfizer
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