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NRx Pharmaceuticals Files New Breakthrough Therapy Designation Request for ZYESAMI® (aviptadil) in Subgroup of Patients with Critical COVID-19 with Respiratory Failure that were also treated with Remdesivir and continued to progress
Breakthrough Therapy designation was requested based on data from post-hoc analysis of patients who in addition to Aviptadil or placebo were also treated with
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"Breakthrough Therapy designation was requested based on data from post-hoc 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.Submission includes cumulative safety data of approximately 750 patients treated with intravenous ZYESAMI® for Critical COVID-19RADNOR, Pa., April 21, 2022 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (\"NRx Pharmaceuticals\"), a clinical-stage, biopharmaceutical company, today announced that it has filed a new Breakthrough Therapy designation request with the U.S. Food and Drug Administration (FDA) focused on a subgroup of patients with Critical COVID-19 that in addition to aviptadil or placebo were also treated with remdesivir. The request includes safety data on approximately 750 patients treated with intravenous ZYESAMI® for Critical COVID-19.\n\n \n \n \n \n \n \n\n \nNRx Files New BTD: ZYESAMI® shows highly significant four-fold increased odds of survival compared to placebo @ 60 daysNRx Pharmaceuticals submitted a Breakthrough Therapy designation request at the end of September 2021, which the FDA did not grant. In its reply, the FDA requested new clinical evidence comparing the safety and efficacy of aviptadil relative to other existing therapies for Critical COVID-19, such as remdesivir. Based on the FDA's input, NRx Pharmaceuticals performed a post-hoc analysis of its completed Phase IIb/III study focused on the approximately 70% of patients that continued to progress to COVID-19 respiratory failure that also received treatment with remdesivir. The post-hoc analysis showed that for these patients, who were already treated with remdesivir and continued to progress, ZYESAMI® showed a highly significant four-fold increased odds of survival compared to placebo at 60 days (P=.006). A Breakthrough Therapy designation request with this data had previously been submitted to the FDA, which NRx Pharmaceuticals withdrew to add its recently completed cumulative safety analysis of approximately 750 patients treated with intravenous ZYESAMI® for Critical COVID-19 to the submission. In February, NRx Pharmaceuticals submitted a new Emergency Use Authorization request also focused on this narrower patient population.\n\"In addition to the previously communicated efficacy data from ...