Pfizer Stops Enrolling Standard Risk Patients in Paxlovid Trial

Pfizer says that as a result of a very low rate of death or hospitalization observed in standard risk Covid-19 patients, it will stop enrolling patients into the EPIC-SR trial of Paxlovid (nirmatrelvir [PF-07231332] tablets and ritonavir tablets). A statement says the company will include available data in this month’s planned NDA submission to support the use of Paxlovid in appropriate individuals at high risk of progression to severe illness.

The company says it will focus efforts on generating additional data on Paxlovid in vulnerable populations.

The statement says additional analyses of EPIC-SR data track earlier reports that the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met, and a non-significant 70% relative risk reduction was observed in the key secondary endpoint of hospitalization or death. The updated analysis showed a non-significant 51% relative risk reduction.