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Radnor, Pennsylvania, December 29, 2021 /PRNewswire/ – NRx Pharmaceuticals (NASDAQ:NRXP) Announced today that it has submitted a new breakthrough therapy designation (BTD) application to the U.S. Food and Drug Administration (FDA), focusing on patients with severe COVID-19 and respiratory failure, despite the use of Remdesivir and other Drugs are used for treatment, but there is still a direct risk of death. Approved therapies.
NRx submitted the request after the FDA requested the clinical data of ZYESAMI ® and Remdesivir for these high-risk patients. professor. David Schoenfield, One of the most widely published statisticians in the world, has unique expertise in life-threatening lung diseases and has performed new analyses.
ZYESAMI® (aviptadil) in a randomized trial of 196 patients showed that compared with placebo, in all patients and hospitals, the survival rate tripled, which was statistically significant. However, among 70% of patients who have been treated with Remdesivir and continue to progress despite all approved treatments, ZYESAMI has shown that compared with placebo, the survival rate at 60 days is significantly increased by 4 times (P = .006) . In addition, compared with placebo, patients who were treated with ZYESAMI after remdesivir failure were three times more likely to survive without respiratory failure at 28 and 60 days (P = .03).
The FDA recently rejected ZYESAMI’s Emergency Use Authorization (EUA) and Breakthrough Therapy Designation (BTD), and invited a new request based on new clinical evidence that avitadil may be in…
The full story on Benzinga.com
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