The submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated people at high risk for progression to severe illness from COVID-19.
Pfizer has submitted a new drug application (NDA) to the FDA for approval of Paxlovid (nirmatrelvir and ritonavir) for patients who are at high risk for progression to severe illness from COVID-19. Paxlovid is currently authorized for emergency use for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older). The submission provides the longer-term follow-up data necessary for acceptance and potential approval.
“Data from our clinical development program, coupled with the more than 1.7 million patients around the world who have been prescribed our oral treatment to date, reinforce PAXLOVID as an important treatment option for mild-to-moderate COVID-19 in patients at greater risk of progression to severe symptoms, regardless of vaccination status,” Albert Bourla, chairman and chief executive officer, Pfizer, said in a press release.
The submission is supported by non-clinical and clinical data and includes results from the phase 2/3 EPIC-HR study, which found that, compared with placebo, treatment with Paxlovid reduced the risk of hospitalization or death from any cause by 88% in non-hospitalized, high-risk adult patients treated within five days of symptom onset. The results showed an 86% reduction in relative risk.
The submission is also comprised of the most recent analyses from the phase 2/3 EPIC-SR study, which included data from both vaccinated patients with, and unvaccinated patients without, risk factors for severe COVID-19. While the primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met, the data were supportive of the efficacy and safety data observed in EPIC-HR for use in patients at increased risk of progression to severe COVID-19 illness.
An integrated analysis of both studies showed an 84% reduction hospitalizations or death, compared with placebo and regardless of vaccination status, in patients with at least one risk factor for progression to severe COVID-19.
Additionally, data from the EPIC-HR, EPIC-SR and EPIC-PEP studies showed a consistent reduction in viral load with Paxlovid, including across both the delta and omicron variant.
Available safety data is consistent in more than 3,500 trial participants across the EPIC clinical development program.