Tuesday, June 15, 2021 9:43:36 AM
- Expanded Access Protocol (EAP) Included 240 ICU Patients Suffering Critical COVID-19 with Respiratory Failure who had Exhausted All Approved Therapies
- Sixty-Five Percent of Patients Receiving ZYESAMI™ (Aviptadil) and Maximal Intensive Care were Alive at 28 Days
- Survival was Higher in those Treated with High Flow Nasal Cannula than those Treated with Mechanical Ventilation (76% vs. 54%)
- Results from EAP are Congruent with the Randomized Control Phase 2b/3 ZYESAMI™ (Aviptadil) Trial Data Submitted to US Food and Drug Administration (FDA) in Support of Emergency Use Authorization (EUA)
- EAP Data to be Submitted to US FDA in Support of EUA Filing
"We initiated the ZYESAMI™ EAP at FDA's request, to gain real-world evidence from patient outcomes outside of the clinical trial environment. Working with 42 U.S. medical centers and hospitals, we were able to see the outcomes ZYESAMI™ provided to some of sickest of COVID-19 patients," said Jonathan Javitt, MD, MPH, CEO and Chairman of the Board, of NRx. "While vaccinations have markedly reduced the incidence of COVID-19 in some countries, effective medicines remain critical for the tens of thousands who continue contracting COVID-19 and the expanding numbers of variants associated with this virus."
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