NRx Pharma: FDA Declines To Issue Emergency Use Authorization For ZYESAMI

NRx Pharmaceuticals, Inc. (NRXP) said FDA has declined to issue an Emergency Use Authorization for ZYESAMI for a sub-group of patients with Critical COVID-19 at immediate risk of death from respiratory failure despite treatment with approved therapy, including remdesivir.

"Though disappointing, this decision by the FDA is not unexpected, given that they had already recently declined Breakthrough Therapy Designation for ZYESAMI. We will evaluate the options for ZYESAMI in COVID-19 respiratory failure and other lung disorders once we receive the full data set from the National Institutes of Health," said Robert Besthof, interim CEO, NRx Pharmaceuticals.

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