Breakthrough Therapy Designation Request for Patients at Immediate Risk of COVID-19 Death

NRx filed the request after the FDA’s request for clinical data on ZYESAMI® vs. Remdesivir in these high risk patients. Prof. David Schoenfeld, one of the world’s most widely published statisticians with unique expertise in life-threatening diseases of the lung conducted the new analysis.

ZYESAMI® (aviptadil) has demonstrated a statistically significant two-fold increased odds of survival compared to placebo across all patients and hospitals studied in a randomized trial of 196 patients.  However, in 70% of patients who were already treated with Remdesivir and continued to progress despite all approved therapies, ZYESAMI has demonstrated a highly significant four-fold increased odds of survival compared to placebo at 60 days (P=.006). Moreover, those treated with ZYESAMI after Remdesivir has failed demonstrate a 3-fold increased odds of being both alive and free of respiratory failure at both 28 and 60 days, compared to placebo (P=.03).

The FDA recently declined Emergency Use Authorization (EUA) and Breakthrough Therapy Designation (BTD) for ZYESAMI and invited a new request based on new clinical evidence that aviptadil may demonstrate a significant improvement in treatment over existing therapies. Based on the FDA’s input, NRx has narrowed its BTD request to treatment of COVID-19 respiratory failure in patients who progress despite treatment with remdesivir and other approved therapies.

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