Paxlovid Updated Data Disappoints Standard-Risk COVID-19 Patients

New York-based Pfizer Inc. recently shared data from the Phase 2/3 EPIC-SR study evaluating the use of PAXLOVID™ in patients at standard risk for developing severe COVID-19.

In an updated analysis through December 2021, Paxlovid showed a non-significant 51% relative risk reduction (treatment arm: 5/576; placebo: 10/569).

And a subgroup analysis of 721 vaccinated adults with at least one risk factor for progression to severe COVID-19 showed a non-significant 57% relative risk reduction in hospitalization or death (treatment arm: 3/361; placebo: 7/360).

Additional secondary endpoint data analyses showed that treatment with PAXLOVID resulted in a nominally significant 62% decrease in COVID-19-related medical visits per day across all patients relative to placebo (p=0.0228).

An additional pre-specified descriptive analysis showed a 72% reduction in the average number of days in hospital among PAXLOVID-treated patients versus placebo in EPIC-SR.

Other not statistically significant findings included no PAXLOVID-treated patients admitted to the intensive care unit, compared to three in the placebo group, and no deaths in patients who received PAXLOVID with one death in the placebo group.

The rates of serious adverse events (1.4% vs. 1.9%) and discontinuation of the study drug due to adverse events (1.7% vs. 1%) were also comparable between PAXLOVID and placebo.

“Results from our Phase 2/3 EPIC-HR and EPIC-SR studies, as well as post-authorization experience, support the efficacy and safety profile for PAXLOVID in the treatment of mild-to-moderate COVID-19 patients with at least one risk factor for progressing to severe COVID-19, regardless of vaccination status,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer, in a press release issued on June 14, 2022.

Due to a very low rate of hospitalization or death observed in the standard-risk patient population, Pfizer has decided to cease enrollment into EPIC-SR and include available data in this month’s planned New Drug Application submission to the U.S. FDA to support the use of PAXLOVID in appropriate individuals at high risk of progression to severe illness.

The company will focus on generating further data on PAXLOVID in vulnerable populations, including longer treatment durations in immunocompromised individuals.

Analyses of the data are ongoing, and final results will be made available via publication or presentation.

PAXLOVID is currently approved or authorized for conditional or emergency use in more than 65 countries across the globe to treat high-risk COVID-19 patients.

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