Request for EUA for sabizabulin to treat hospitalized COVID-19 patients at high risk for ARDS is not accepted by FDA - Veru Inc.,

In communicating its decision, the FDA stated that despite the FDA declining to issue an EUA for sabizabulin at this time, the FDA remains committed to working with the Company for the development of sabizabulin.

The FDA also provided comments on a proposed confirmatory Phase III study protocol submitted by the Company for hospitalized moderate to severe COVID-19 patients at risk for ARDS and death that could support a new EUA authorization and/or NDA approval. FDA stated that in the potential confirmatory Phase III clinical study design: “strong consideration should be given to appropriate time frames for interim analyses so that – should a strong efficacy signal again be observed – the trial could be stopped in an efficient time frame.” Veru expects to communicate the details of the design and timing of this potential Phase 3 confirmatory study soon. It should be noted that in the U.S. Department of Health and Human Services’ (HHS) fact sheet published on February 9, 2023, HHS and FDA made clear that FDA’s ability to continue authorizing new COVID-19 therapeutics for emergency use is not impacted by the ending of the declaration of the U.S. public health emergency on May 11, 2023.