Pfizer's Oral COVID-19 Pill Seeks FDA Authorization

New York-based Pfizer Inc. today announced PAXLOVID™ (PF-07321332) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19.

In the overall clinical study population through Day 28, no deaths were reported in patients who received PAXLOVID compared to 10 deaths in patients who received placebo.

The primary analysis of the interim data set evaluated data from 1,219 adults who were enrolled by September 29, 2021.

Pfizer confirmed plans to submit the data as part of its ongoing rolling submission to the U.S. FDA seeking Emergency Use Authorization for its investigational novel COVID-19 oral antiviral candidate.

Mikael Dolsten, MD, PhD., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer, commented in a press release, “We’re thankful to all of the patients, investigators, and sites around the world who participated in this clinical trial, all with the common goal of bringing forth a breakthrough oral therapy to help combat COVID-19.”

The Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) and EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) studies, which began in August and September 2021, respectively, were not included in this interim analysis and are ongoing.