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Pfizer starts global phase II/III EPIC-PEP study of novel COVID-19 antiviral PF 07321332 for post exposure prophylaxis.
Pfizer Inc announced the start of the Phase II/III EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study to evaluate the investigational novel oral antiviral candidate PF 07321332, co-administered with a low dose of ritonavir, for the prevention of COVID-19 infection.
Oral COVID-19 antiviral, Paxlovid is approved by MHRA (UK).
Pfizer UK announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorisation for Great Britain for the supply and use of PF-07321332/ritonavir for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe disease.
Phase II/III study of novel COVID-19 oral treatment Paxlovid, is initiated in pediatric participants.- Pfizer
Pfizer Inc. announced that it has initiated a Phase II/III study, EPIC-PEDS (Evaluation of Protease Inhibition for COVID-19 in Pediatric Patients), to evaluate the safety, pharmacokinetics, and efficacy of Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) in non-hospitalized, symptomatic, pediatric participants with a confirmed diagnosis of COVID-19 who are at risk of progression to severe disease.
Phase II evaluation of anti-MAdCAM antibody PF-00547659 in the treatment of Crohn's disease: report of the OPERA study.
This phase II, randomised, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of PF-00547659, a fully human monoclonal antibody that binds to human mucosal addressin cell adhesion molecule...
Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease (OPERA)
Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug).
REFLECTIONS B7391003 study, of biosimilar PF-06439535 versus Avastin (bevacizumab), met its primary objective for treatment of NSCLC.- Pfizer
Pfizer Inc. announced that the REFLECTIONS B7391003 study, a comparative, confirmatory safety and efficacy study of PF-06439535 versus Avastin (bevacizumab),...
Submission of NDA to the FDA for Paxlovid full approval.- Pfizer
Pfizer Inc. announced the submission of a New Drug Application (NDA) to the FDA for approval of Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for patients who are at high risk for progression to severe illness from COVID-19.
Additional data from EPIC-SR study for Paxlovid to support upcoming NDA submission to FDA.
Pfizer Inc. shared data from the Phase II/III 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.