Posted by Michael Wonder on 12 Jun 2022
NRx Pharmaceuticals provides update on breakthrough therapy designation request for Zyesami (aviptadil)
10 June 2022 - NRx Pharmaceuticals today announced that the U.S. FDA denied the breakthrough therapy designation request for Zyesami (aviptadil) and emphasised its focus on the company's NRX-101 breakthrough therapy designation compound for bipolar depression associated with suicidality.
The request for breakthrough therapy designation was submitted based on the positive finding of a post-hoc subgroup analysis of patients who in addition to aviptadil or placebo were also treated with remdesivir and whose respiratory failure due to critical COVID-19 continued to progress.
