The Final Effective Rate Of Pfizer's Oral New Covid Drug Is 89%

On December 15th, Pfizer announced its new COVID-19 oral antiviral drug candidate Paxlovid (nirmatrelvir tablets (PF-07321332); ritonavir tablets) for the treatment of non-hospitalized patients with high risk of developing severe diseases in adults with COVID-19 infection The final analysis results of the randomized, double-blind phase II/III EPIC-HR study.

The final analysis results of the study are consistent with the results of the interim analysis announced in November 2021. Among patients treated within three days of the onset of symptoms, Paxlovid can increase the risk of COVID-19-related hospitalization or death from any cause compared with placebo. Reduced by 89%.

In terms of secondary endpoints, among patients treated within five days of the onset of symptoms, Paxlovid can reduce the risk of COVID-19-related hospitalization or death from any cause by 88% compared with placebo, which is higher than the 85 observed in the interim analysis. %. As part of the emergency use authorization (EUA) data submission, Pfizer has submitted these data to the US FDA on a rolling basis.

The SARS-CoV-2 viral load test of 499 patients in the EPIC-HR trial showed that compared with placebo, the viral load on day 5 of the Paxlovid group was reduced by about 10 times compared with the baseline, indicating that Paxlovid is against SARS-CoV-2 has strong activity and is the strongest reduction in viral load among oral COVID-19 preparations reported so far.

Another interim analysis of the Phase II/III study code-named EPIC-SR showed that for unvaccinated adults and vaccinated adults with one or more risk factors for progression to severe disease, Paxlovid did not reach patients A self-reported new primary endpoint of sustained relief of all symptoms for four consecutive days.

The key secondary endpoint showed that compared with placebo, the hospitalization rate of the treated population was reduced by 70%, and there were no deaths. In addition, compared with placebo, the viral load was reduced by about 10 times, which is consistent with the results of the Phase II/III EPIC-HR study.

Recent in vitro data confirmed that nirmatrelvir is an effective inhibitor of Omi Keron 3CL protease. Combined with other existing variants of interest (VoC) including Delta's in vitro antiviral and protease inhibition data, it shows that Paxlovid will maintain strong antiviral activity against VoC and other coronavirus variants.