Pfizer Seeks EUA for COVID-19 Oral Antiviral

If authorized, Paxlovid would be the first oral 3CL protease inhibitor specifically designed to combat the virus that causes COVID-19.

Pfizer has submitted an application for emergency use authorization for Paxlovid (ritonavir), an oral antiviral for the treatment of mild-to-moderate COVID-19 in patients at increased risk of hospitalizations or death.

If authorized, this would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2.

“With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options. The overwhelming efficacy achieved in our recent clinical study of Paxlovid, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,” Albert Bourla, chairman and CEO of Pfizer, said in a statement.

Related: Pfizer’s COVID-19 Antiviral Cuts Hospitalization, Deaths

This submission includes clinical data from the phase 2/3 EPIC-HR, which enrolled non-hospitalized adults aged 18 and older with confirmed COVID-19 who are at increased risk of progressing to severe illness.

The data demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death from any cause in patients treated with Paxlovid compared with placebo within three days of symptom onset, with no deaths in the treatment group.

Similar results were seen with within five days of symptom onset. Treatment-emergent adverse events were comparable to placebo, most of which were mild in intensity. A

Pfizer had begun a rolling submission of Paxlovid and submitting nonclinical data in October 2021. Rolling submissions have begun in several countries, including in the United Kingdom, Australia, New Zealand and South Korea