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NRx Pharmaceuticals Submits Emergency Use Authorization Application to US Food and Drug Administration for ZYESAMI® (aviptadil) to Treat Patients at Immediate Risk of Death from COVID-19 Despite Treatment with Remdesivir and Other Approved Therapies
- Requested indication focuses on patients whose respiratory failure has progressed despite treatment with Remdesivir or other approved therapies - Patients
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"- Requested indication focuses on patients whose respiratory failure has progressed despite treatment with Remdesivir or other approved therapies\n - Patients treated with ZYESAMI vs. placebo demonstrated statistically significant (P=.03), 2.8-fold increased odds of being alive and free of respiratory failure at day 28 and day 60 and a 4-fold increased odds of surviving to 60 days (P=.006)\n - Patients at highest risk - those on ventilators at time of randomization - demonstrated a 10-fold increased odds of survival (P=.03)\n - US National Institutes of Health-sponsored trial comparing ZYESAMI and Remdesivir individually and in combination continues to demonstrate safety and has enrolled more than 350 patients\n\n\nRADNOR, Pa., Jan. 5, 2022 /PRNewswire/ -- 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..\n\n \n \n \n \n \n \n\n \n\"We appreciate the detailed feedback and learnings from our previous EUA submission, and applied them to this narrower request to the FDA,\" said Prof Jonathan Javitt, MD, MPH, Chairman and CEO NRx Pharmaceuticals. \"As the Omicron surge continues to push our hospitals far past capacity, and with more than 1200 Americans dying every day, we continue to believe ZYESAMI can provide an option to the sickest of COVID patients who have no other options and significantly increase their chances at recovering.\"\nThe filing comes with a new analysis of the Phase 2b/3 data of ZYESAMI in patients treated with Remdesivir or other approved or authorized medicines for critical COVID-19. The new analysis was conducted by Prof. David Schoenfeld, PhD, an expert statistician with unique expertise in life-threatening diseases of the lung. The analysis, requested by the FDA, demonstrated that the odds of meeting the original primary endpoint of the trial, being \"alive and free of respiratory failure at 28 days\" were 2.8-fold higher on ZYESAMI than on placebo (P=.03). There was a 4 fold increased odds of surviving to 60 days (P...