Pre-Emergency Use Authorization Meeting Granted for COVID-19 Treatment

Florida-based Veru Inc. today announced that the U.S. FDA granted the Company a pre-Emergency Use Authorization (EUA) meeting regarding the positive Phase 3 COVID-19 study results for sabizabulin. 

Treatment with sabizabulin 9mg once daily, an oral, first-in-class, new chemical entity, cytoskeleton disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55% relative reduction in deaths.

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 Committee unanimously halted the study for overwhelming efficacy and safety.

“We appreciate FDA’s actions to expedite this process as COVID-19 cases are on the rise again,” said Mitchell S. Steiner MD, Chairman, President, and CEO of Veru Inc., in a press release issued on May 2, 2022.

The FDA previously granted Fast Track designation to the Company’s COVID-19 program in January 2022.

Additional COVID-19 antiviral and treatment news is posted at PrecisionVaccinations.com/Antivirals.

Note: The company's announcement was curated for mobile readership.