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NRx Pharmaceuticals Files Application With FDA For Emergency Use Authorization Of ZYESAMI In COVID-19


Benzinga | Jun 1, 2021 06:30AM EDT

NRx Pharmaceuticals Files Application With FDA For Emergency Use Authorization Of ZYESAMI In COVID-19

NRx Pharmaceuticals (NASDAQ:NRXP) (NRx), a clinical stage pharmaceutical company, today announced it has filed an application with U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for ZYESAMI(tm) (Aviptadil-acetate), to treat Critically Ill COVID-19 patients suffering with respiratory failure. Consistent with previously announced top-line data, the study identified a statistically significant increase in the likelihood that patients treated with ZYESAMI(tm) would be alive and free of respiratory failure at 60 days, compared to those treated with placebo, and identified a significantly shorter median hospital stay.1 The clinical study report filed with FDA further documents statistically significant advantages for ZYESAMI(tm) on all major secondary endpoints.






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