FDA Approves Pfizer's COVID-19 Pill

The relative risk reduction was 94% in patients 65 years of age or older in clinical trials.

This article was originally published in ContagionLive.

The US Food and Drug Administration (FDA) has approved Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to treat patients with COVID-19.

The pill is indicated for people with COVID-19 in trying to prevent them from progressing to more severe disease including hospitalization.

"Today's authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally—a major step forward in the fight against this global pandemic," Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research, stated. "This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19."

This news comes less than 2 weeks after Pfizer reported data on the investigational therapy. At that time, the company reported that Paxlovid reduced the risk of hospitalization or death by 89% (within 3 days of symptom onset) and 88% (within 5 days of symptom onset) compared to placebo. There were no deaths compared to placebo in non-hospitalized, high-risk adults with COVID-19.

These results stem from the company’s EPIC-HR study, which enrolled 2246 participants and 0.7% of patients who received Paxlovid were hospitalized through day 28 following randomization (n = 5 hospitalized with no deaths), compared to 6.5% of patients who received placebo and were hospitalized or died (n = 44 hospitalized with 9 subsequent deaths).

According to the company, relative risk reduction was 94% in patients 65 years of age or older, one of the populations at highest risk for hospitalization or death; 1.1% of patients who received (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) were hospitalized through Day 28 (n = 1 hospitalized with no deaths), compared to 16.3% of patients who received placebo (n = 16 hospitalized with 6 deaths), with high statistical significance (p<0.0001). In the overall study population through Day 28, no deaths were reported in patients who received Paxlovid as compared to 12 (1.2%) deaths in patients who received placebo.

“This news provides further corroboration that our oral antiviral candidate, if authorized or approved, could have a meaningful impact on the lives of many, as the data further support the efficacy of Paxlovid in reducing hospitalization and death and show a substantial decrease in viral load. This underscores the treatment candidate’s potential to save the lives of patients around the world,” Pfizer CEO Albert Bourla, said at the time of the data’s release.