FDA Rejects EUA for COVID-19 Respiratory Failure Therapy

The FDA didn’t have enough data to assess the risks and benefits of Zyesami.

The FDA has declined to issue an emergency use authorization (EUA) for NRx Pharmaceuticals’ Zyesami (aviptadil) to treat patients with COVID-19-related respiratory failure. Regulatory officials said there is not enough data on the risks and benefits of the therapy; officials have reviewed safety data for only 131 randomized patients treated with Zyesami.

NRx officials said in a statement that 150 or more additional patients have already been treated with Zyesami in the National Institutes of Health ACTIV-3b trial. Last week, the study’s data safety and monitoring board found no new safety issues. The NIH study, which has enrolled more than 300 patients, is a confirmatory study that randomized patients with COVID-19 respiratory failure to Zyesami or Veklury (remdesivir) and placebo.

A second nationwide trial to determine if similar benefits may be achieved in critically ill patients with inhaled Zyesami is being conducted on the I-SPY platform, maintained by the Quantum Leap Healthcare Collaborative.

NRx also continues to study the effect of inhaled Zyesami in patients with severe but not critical COVID-19 in a placebo-controlled trial that aims to demonstrate the ability of the therapy. to keep patients from requiring intensive care.

“We believe that Zyesami has demonstrated a high degree of safety and a two-fold increase in the odds of surviving the ICU. Patients treated at the nation’s top hospitals with Zyesami had a four-fold increase in odds of survival. 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,” Jonathan Javitt, M.D., chief executive officer of NRx said in a statement.