After Merck Co & Inc MRK, now Pfizer Inc PFE has unveiled data for its COVID-19 oral antiviral candidate, Paxlovid. Paxlovid is an investigational SARS-CoV-2 protease inhibitor antiviral therapy.
What Happened: The interim data of the Phase 2/3 EPIC-HR study showed an 89% reduction in risk of COVID-19-related hospitalization or death compared to placebo in patients treated within three days of symptom onset (primary endpoint).
Merck shared data for its oral COVID-19 antiviral almost a month ago, demonstrating a 50% reduction in death or hospitalization. 0.8% of Paxlovid patients were hospitalized through Day 28 (3/389 hospitalized with no deaths), compared to 7.0% of placebo patients who were hospitalized or died (27/385 hospitalized with 7 subsequent deaths).
Similar reductions in COVID-19-related hospitalization or death were observed in patients treated within five days of symptom onset.
Independent Data Monitoring Committee and FDA have recommended Pfizer cease further enrollment into the study due to the overwhelming efficacy.
Why It Matters: Pfizer plans to submit the data as part of its ongoing rolling submission to FDA for Emergency Use Authorization (EUA) as soon as possible.
The review of safety data included a larger cohort of 1881 patients.
Treatment-emergent adverse events were comparable between Paxlovid (19%) and placebo (21%), most of which were mild in intensity.
Related: Pfizer More Than Doubles Earnings, Sales In Q3; Forecasts $36B From COVID-19 Vax Sales In FY21.
Price Action: PFE shares are up 11.3% at $48.80 during the premarket session on the last check Friday.
Photo by Thomas Breher from Pixabay
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