FDA decline Emergency Use Authorisation for ZYESAMI® in patients with critical COVID

pharmafile | November 5, 2021 | News story | Medical Communications  

The FDA has declined to grant Emergency Use Authorisation for NRx Pharmaceuticals’ therapy, Zyesami® (aviptadil), in the treatment of critical COVID-19 patients. The FDA cited insufficient data regarding the benefits of Zyesami versus the risks in patients suffering from COVID with respiratory failure.

NRx will attempt to coordinate a review by the FDA of 150 or more additional patients already treated with Zyesami in the ACTIV-3b Critical Care clinical trial sponsored by the NIH.

“We believe that Zyesami has demonstrated a high degree of safety and a two-fold increase in the odds of surviving the ICU,” NRx Pharmaceuticals board chairman and CEO Jonathan Javitt said. “We will work actively with the FDA to deliver the data it has requested so that we may offer those patients another chance at life and have asked the FDA for a Type A meeting that will include the experience of physicians who have witnessed the effects of our medicine firsthand and the experience of patients who are alive today because they were given one last chance at life.”

“Yesterday, more than 1,500 Americans and many more around the world died lonely deaths from COVID-19, isolated from their loved ones in ICUs despite widespread vaccination and currently-available approved treatments,” Javitt said. “Patients treated at the nations top hospitals with Zyesami had a four-fold increase in odds of survival.”

NRx Pharmaceuticals is a clinical-stage biopharmaceutical company. Zyesami has been granted Fast Track designation by the FDA and is currently undergoing Phase III trials for patients with COVID-19, funded by the NIH, the Biomedical Advanced Research and Development Authority, part of the Department of Health and Human Services, and the Medical Countermeasures program.

Ana Ovey

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