NRx Pharmaceuticals, Inc. today announced that it has filed a new Breakthrough Therapy designation request with the U.S. Food and Drug Administration (FDA) focused on a subgroup of patients with Critical COVID-19 that in addition to aviptadil or placebo were also treated with remdesivir. The request includes safety data on approximately 750 patients treated with intravenous ZYESAMI® for Critical COVID-19.
NRx Pharmaceuticals (Nasdaq: NRXP) announced today that it has submitted an application for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) for the use of ZYESAMI® (aviptadil) in patients with Critical COVID-19 who are at immediate risk of death from Respiratory Failure despite treatment with approved therapy including Remdesivir and who are ineligible for enrollment into the ongoing ACTIV-3b NIH-sponsored trial.
NRx Pharmaceuticals Files Breakthrough Therapy Designation Request for ZYESAMI® (aviptadil) in Patients at Immediate Risk of Death from COVID-19.
After Review of More than 348 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Identified by Independent Data Safety Monitoring Board; Study Cleared to Continue Enrollment to Target 640 Patients First Patient in Brazil Expected to be Included in US National Institutes of Health (NIH) Trial in February 2022 ACTIV-3b Critical Care […]
After Review of More than 300 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board; Study Cleared to Continue Enrollment to Target 640 Patients ACTIV-3b Critical Care Study is Evaluating ZYESAMI® (aviptadil) and Remdesivir, in Critical COVID-19 Patients, as Monotherapy and in Combination Against Placebo ACTIV-3b […]
After Review of Approximately 140 patients in ACTIV-3 Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board, Study to Continue Enrollment to Target More than 600 Patients ACTIV-3 Critical Care is a Public-Private Partnership Sponsored by the US National Institutes of Health to Treat COVID-19 ACTIV-3 Critical Care is Evaluating […]
PR Newswire RADNOR, Pa., April 26, 2021 /PRNewswire/ — Dosing of the first patient in a phase 3 clinical trial of ZYESAMI (aviptadil acetate) was announced by the National Institutes of Health (NIH) last week. The trial, designated as ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 (TESICO) (www.clinicaltrials.gov NCT04843761), will study ZYESAMI to treat severely ill COVID-19 patients. The […]
Patients with acute respiratory failure may now enroll in NIH-sponsored trial. National Institutes of Health – News Releases A new Phase 3 trial to test the safety and efficacy of therapeutics for COVID-19 has begun enrolling patients hospitalized with life-threatening cases of COVID-19, including those with acute respiratory failure. The trial is supported by two […]