FDA Declines NRx’s EUA for Zyesami a Second Time

The FDA has declined NRx Pharmaceuticals’ Emergency Use Authorization (EUA) application a second time for Zyesami (aviptadil), this time for a subgroup of COVID-19 patients at immediate risk of death due to respiratory failure despite treatment with an approved therapy, including remdesivir.

In November 2021, the agency declined to authorize Zyesami for critical COVID-19 patients with respiratory failure because of insufficient data regarding benefits and risks of the drug.

The FDA previously denied the company’s request for a Breakthrough Therapy designation for Zyesami last June.

Zyesami, which is an inhaled formulation of a synthetic human intestinal peptide, has been administered under the FDA’s expanded access and right-to-try programs, which made the drug accessible to patients with no other treatment options.