Pfizer seeks FDA EUA for COVID-19 treatment

Nov. 17, 2021

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.

Visit Pfizer for more news

More on COVID