Florida-based Veru Inc. today announced that the U.S. FDA has granted the company a Pre-Emergency Use Authorization (EUA) meeting regarding positive Phase 3 COVID-19 study results. for sabizabulin.
Treatment with sabizabulin 9 mg once daily, a first-in-class new oral chemical entity, cytoskeletal disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically and statistically significant 55% relative reduction in death.
The FDA meeting is scheduled for May 10, 2022.
The double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in approximately 210 hospitalized COVID-19 patients with moderate to severe COVID. Based on a planned interim analysis of the first 150 patients to complete 60 days of follow-up, the independent data monitoring board unanimously stopped the study for overwhelming efficacy and safety.
“We appreciate the actions of the FDA to expedite this process as COVID-19 cases are on the rise again,” said Mitchell S. Steiner MD, chairman, president and chief executive officer of Veru Inc., in a statement. press release published on May 2, 2022.
The FDA previously granted Fast Track designation to the company’s COVID-19 program in January 2022.
Additional information on antivirals and COVID-19 treatments is posted at PrecisionVaccinations.com/Antivirals.
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