Pfizer is seeking emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its investigational oral antiviral candidate, PAXLOVID, for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death.
This submission to the U.S. Food and Drug Administration (FDA) includes clinical data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) interim analysis. Rolling submission of non-clinical data for PAXLOVID was initiated with the FDA in October 2021, Pfizer said.
If authorized or approved, PAXLOVID would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2 that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness, which can lead to hospitalization and death.
Pfizer also announced that it has signed a voluntary license agreement for its COVID-19 oral antiviral treatment candidate PF-07321332, which is administered in combination with low dose ritonavir (PF-07321332; ritonavir). The licensing agreement will allow Medicines Patent Pool (MPP), a United Nations-backed public health organization, to facilitate additional production and distribution of the investigational antiviral, pending regulatory authorization or approval, by granting sub-licenses to qualified generic medicine manufacturers, with the goal of facilitating greater access to the global population.
MPP works to increase access to life-saving medicines for low- and middle-income countries.
