Emergency Use Authorization Application to FDA for sabizabulin, for hospitalized COVID-19 patients at high risk for ARDS.
Veru Inc. announced that is has submitted an emergency use authorization (EUA) application to the FDA for its sabizabulin (VERU 111) oral 9mg treatment of moderate to severe hospitalized COVID-19 patients at high risk for developing Acute Respiratory Distress Syndrome (ARDS).
The EUA submission to the FDA is based on the positive results from the double-blind, randomized, multicenter placebo-controlled Phase III COVID-19 clinical trial evaluating the efficacy and safety of sabizabulin, an oral, first-in-class, new chemical entity, cytoskeleton disruptor that has dual anti-inflammatory and antiviral properties, in approximately 204 hospitalized COVID-19 patients with moderate to severe COVID ( greater than WHO 4-supplemental oxygen) at high risk for ARDS and death.
The primary efficacy endpoint was the proportion of deaths by Day 60. Based on a planned interim analysis of the first 150 patients randomized, the Independent Data Monitoring Committee unanimously halted the study for overwhelming efficacy which showed that sabizabulin 9mg once daily treatment resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths. Sabizabulin was well tolerated.
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