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NRx Pharma Files New Breakthrough Therapy Designation Request For ZYESAMI

NRx Pharmaceuticals, Inc. (NRXP) has filed a new Breakthrough Therapy designation request with the FDA focused on a subgroup of patients with critical COVID-19 that in addition to aviptadil or placebo were also treated with remdesivir. The company submitted a Breakthrough Therapy designation request at the end of September 2021, which the FDA did not grant. NRx Pharma noted that its new request was 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.

"In addition to the previously communicated efficacy data from the post-hoc analysis, this Breakthrough Therapy designation request also includes safety data of approximately 750 patients across all programs of intravenous ZYESAMI in Critical COVID-19 as of early February 2022," said Robert Besthof, interim CEO of NRx Pharmaceuticals.

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