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NRx Pharmaceuticals Files Breakthrough Therapy Designation Request for ZYESAMI® (aviptadil) in Patients at Immediate Risk of Death from COVID-19 Despite Treatment with Remdesivir and Other Approved Therapies
- Breakthrough Therapy Designation request focused on patients whose respiratory failure has progressed despite treatment with Remdesivir - Filing is based on
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"- Breakthrough Therapy Designation request focused on patients whose respiratory failure has progressed despite treatment with Remdesivir\n - Filing is based on FDA request for clinical data on the effectiveness of ZYESAMI compared to Remdesivir and other approved therapies\n - Patients treated with ZYESAMI vs. placebo demonstrated a statistically significant (P=.03) 2.8-fold increased odds of being alive and free of respiratory failure at day 28 and day 60\n - A highly significant (P=.006) four-fold increased odds of survival is seen in these patients\n - Patients at the highest risk - those on ventilators at time of randomization - demonstrated a 10-fold increased odds of survival (P=.03)\n - US National Institutes of Health-sponsored trial comparing ZYESAMI and Remdesivir individually and in combination continues to demonstrate safety and has enrolled more than 350 patients\n\n\nRADNOR, Pa., Dec. 29, 2021 /PRNewswire/ -- NRx Pharmaceuticals (Nasdaq: NRXP) announced today that it has filed a new Breakthrough Therapy Designation (BTD) request with the US Food and Drug Administration (FDA) focused on patients with Critical COVID-19 and respiratory failure who are at immediate risk of death despite treatment with remdesivir and other approved therapies.\n\n \n \n \n \n \n \n\n \nWith the FDA's support, we believe we have the chance to help more than 100,000 Americans return to their loved ones who otherwise might not live to see next year's holidays.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.\nZYESAMI® (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...