> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# No Zyesami EUA: FDA
- URL: https://www.fdaweb.com/no-zyesami-eua-fda/
- Published: 2022-07-11T12:00:00.000Z
- Updated: 2026-09-14T17:51:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152233

FDA has declined to issue an emergency use authorization (EUA) for NRx Pharmaceuticals’ Zyesami (aviptadil) for a sub-group of patients that received remdesivir in addition to Zyesami and continued to progress. The company [said](https://www.thepharmaletter.com/article/fda-declines-eua-for-aviptadil-for-patients-with-critical-covid-19-at-immediate-risk?ref=fdaweb.com) the denial was not unexpected given that the agency had recently denied a breakthrough therapy designation for the drug, *thepharmaletter* reports.

At the end of May, the company announced that Zyesami would no longer be evaluated in the NIH-sponsored ACTIV-3b trial in critical Covid-19 patients because of futility. Company officials said that once they receive the full data set from the National Institutes of Health, they will evaluate the options for Zyesami in Covid-19 respiratory failure and other lung disorders.