Posted by Michael Wonder on 04 Jul 2022
FDA declines emergency use authorisation for Zyseami (aviptadil) for sub-group of patients with critical COVID-19 at immediate risk of death from respiratory failure despite treatment with approved therapy, including remdesivir
1 July 2022 - Focus is now on NRX-101 for bipolar depression with suicidality.
NRx Pharmaceuticals today announced that the US FDA has declined to issue an emergency use authorisation for Zyesami (aviptadil) for a sub-group of patients that in addition to Zyesami, also received Remdesivir and continued to progress.
NRx Pharmaceuticals had submitted this last emergency use authorisation application using data from a post hoc sub-group analysis.
