Pfizer: Paxlovid not effective in reducing symptoms in standard risk patients
Pfizer: “An updated analysis from 1,153 patients showed a non-significant 51% relative risk reduction”.
Pfizer today shared data from the Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) study evaluating the use of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) in patients who are at standard risk for developing severe COVID-19.
In previously reported interim analyses, the company disclosed that the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met, and a non-significant 70% relative risk reduction was observed in the key secondary endpoint of hospitalization or death (treatment arm: 3/428; placebo: 10/426). An updated analysis from 1,153 patients enrolled through December 2021 showed a non-significant 51% relative risk reduction (treatment arm: 5/576; placebo: 10/569). A sub-group 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).
Pfizer Reports Additional Data on PAXLOVID™ Supporting Upcoming New Drug Application Submission to U.S. FDA
Pfizer said on Tuesday it would halt enrollment in a trial for its COVID-19 antiviral drug, Paxlovid, in standard-risk patients after a study revealed the treatment was not effective in reducing symptoms in that group.
The drug has emergency use authorization for high-risk groups in which it has been effective in reducing hospitalizations and deaths.
The new data, however, showed a 51% relative risk reduction in standard-risk groups, which the company said was not statistically significant.
Reuters report: Pfizer stops enrollment in Paxlovid trial in standard-risk population
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