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Zyesami filed with FDA for Emergency Use Authorization in COVID-19.- NRx Pharmaceuticals

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Published:2nd Jun 2021
NRx Pharmaceuticals has filed an application with FDA requesting Emergency Use Authorization (EUA) for Zyesami (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 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.

The clinical study report filed with FDA further documents statistically significant advantages for Zyesami on all major secondary endpoints.Patients enrolled in the study had respiratory failure despite prior treatment with all approved medicines for COVID-19 including remdesivir. Other therapies administered included steroids, anticoagulants, and various monoclonal antibodies. Although antiviral treatment has shown advantages in treating patients with earlier stages of COVID-19. Zyesami is the first reported medicine to demonstrate increased recovery and survival in patients who have already progressed to respiratory failure. The randomized controlled trial outcomes remain similarly consistent with the open-label, administratively controlled trial reported in October 2020.

Condition: Coronavirus/ARDS
Type: drug

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