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NRx Seeks Emergency Approval For ZYESAMI To Treat Patients At Immediate Risk Of Death From COVID-19

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

NRx Pharmaceuticals (NRXP) said Wednesday that it has submitted an application for Emergency Use Authorization to the US Food and Drug Administration for the use of ZYESAMI or aviptadil in patients with Critical COVID-19 who are at immediate risk of death from Respiratory Failure despite treatment with approved therapy including remdesivir and who are ineligible for enrollment into the ongoing ACTIV-3b NIH-sponsored trial.

The company noted that patients treated with ZYESAMI vs. placebo demonstrated statistically significant, 2.8-fold increased odds of being alive and free of respiratory failure at day 28 and day 60 and a 4-fold increased odds of surviving to 60 days.

The company stated that patients at highest risk - those on ventilators at time of randomization - demonstrated a 10-fold increased odds of survival.

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