Paxlovid FDA Approval Status
Last updated by Philip Thornton, DipPharm on July 21, 2022.
Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets co-packaged) has emergency use authorization (EUA) from the FDA to treat mild-to-moderate COVID-19 in adults and pediatric patients who are 12 years of age and older and weigh at least 40 kg (88 lbs). Patients must have a positive direct SARS-CoV-2 viral test and be at high risk for progression to severe COVID-19, including hospitalization or death.
- Pfizer filed a New Drug Application (NDA) with the FDA for full regulatory approval of Paxlovid on June 30, 2022.
- Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions.
- Paxlovid is administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days. One box contains five blister packs of Paxlovid, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Treatment should start as soon as possible after a positive SARS-CoV-2 viral test to potentially help patients avoid severe illness.
- Paxlovid contains the novel antiviral nirmatrelvir (PF-07321332) which works by blocking the activity of SARS-CoV-2 main protease (Mpro), also known as SARS-CoV2 3CL protease, an enzyme that the coronavirus that causes COVID-19 needs to replicate. Co-administration with low dose ritonavir helps slow the metabolism of nirmatrelvir allowing it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.
- In vitro data confirm that nirmatrelvir is a potent inhibitor of the Omicron 3CL protease, which, combined with existing in vitro antiviral and protease inhibition data from other Variants of Concern (VoC) including Delta, indicates that Paxlovid will retain robust antiviral activity against current VoCs as well as other coronaviruses.
- Final data from the EPIC-HR study confirmed that Paxlovid reduced risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo.
Development timeline for Paxlovid
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