FDA

The FDA fully approved (2023) drug after initial Emergency Use Authorization (EUA) for the emergency use of Paxlovid (nirmatrelvir/ritonavir) for the treatment of mild-to-moderate COVID-19 disease in adults and children ≥ 12 years of age who are at high risk for progressing to severe COVID-19 illness, including hospitalization and death.

• Risk factors for severe disease include diabetes, overweight (BMI >25), chronic lung disease, chronic kidney disease, current smoker, immunosuppressive disease or immunosuppressive treatment, cardiovascular disease, hypertension, sickle cell disease, neurodevelopmental disorders, active cancer, and patients >60 years of age.
• The FDA removed an earlier requirement for a positive SARS-CoV-2 test from the EUA in February 2023.