NRx Pharmaceuticals Submits Emergency Use Authorization Application to FDA for ZYESAMI

NRx Pharmaceuticals announced 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..

“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.”

The 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=.006).  Patients at highest risk – those on ventilators at time of randomization – demonstrated a 10-fold increased odds of survival (P=.03) after doctors administered ZYESAMI. The most common side effects of ZYESAMI noted were mild to moderate diarrhea and systemic hypotension (low blood pressure).

ZYESAMI (aviptadil) is a synthetic form of Vasoactive Intestinal Polypeptide (VIP) and binds specifically to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung, where it has been shown to have potent anti-inflammatory and anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. VIP stimulates ATII cells to make the surfactant that must coat the lining of the lungs for them to exchange oxygen with the blood.  Loss of surfactant causes respiratory failure and alveolar collapse, hallmarks of COVID-19.

NRx looks forward to working with the FDA and providing further information regarding the EUA submission upon FDA request.

In 2021, the FDA declined to issue EUA for ZYESAMI to treat patients suffering Critical COVID-19 with respiratory failure. This new EUA submission is a narrower, proposed indication for patients with no other available therapy and is supported by data requested by the FDA. ZYESAMI was selected by NIH from among 600 candidate drugs for study in the ongoing Phase 3 ACTIV-3b trial. The revised indication is designed to ensure that enrollment in this trial is not compromised.