Requested indication focuses on patients whose respiratory failure has progressed despite treatment with Remdesivir or other approved therapies
- Patients treated with ZYESAMI vs. placebo demonstrated statistically significant (P=.03), 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 (P=.006)
- Patients at highest risk - those on ventilators at time of randomization - demonstrated a 10-fold increased odds of survival (P=.03)
- US National Institutes of Health-sponsored trial comparing ZYESAMI and Remdesivir individually and in combination continues to demonstrate safety and has enrolled more than 350 patients
https://finance.yahoo.com/news/nrx-pharmaceuticals-submits-emergency-authorization-114800038.html
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