Pfizer has announced results from an analysis of 2,246 adults enrolled in its Phase II/III EPIC-HR (Evaluation of Protease Inhibition for Covid-19 in High-Risk Patients) trial of its novel Covid-19 oral antiviral candidate Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets).
These results show that Paxlovid significantly reduced the risk of hospitalisation or death for any cause by 89% compared to placebo in non-hospitalised, high-risk adult patients with Covid-19 treated within three days of symptom onset.
It was also shown that Paxlovid reduced the risk of hospitalisation or death for any cause by 88% compared to placebo in patients treated within five days of symptom onset, an increase from the 85% observed in the interim analysis.
The EPIC-HR data have been shared with the US Food and Drug Administration (FDA) as part of an ongoing rolling submission for Emergency Use Authorisation (EUA).
“This news provides further corroboration that our oral antiviral candidate, if authorised or approved, could have a meaningful impact on the lives of many, as the data further support the efficacy of Paxlovid in reducing hospitalisation and death and show a substantial decrease in viral load. This underscores the treatment candidate’s potential to save the lives of patients around the world,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Emerging variants of concern, like Omicron, have exacerbated the need for accessible treatment options for those who contract the virus, and we are confident that, if authorised or approved, this potential treatment could be a critical tool to help quell the pandemic.”
Image credit: Ksenia Yakovleva