Business
Veru Provides FDA Update on Request for Emergency Use Authorization for Sabizabulin for Hospitalized COVID-19 Patients at High Risk for ARDS
MIAMI, FL, March 02, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and
About this update from Veru Inc.
[{"type":"text","content":"MIAMI, FL, March 02, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced that the U.S. Food and Drug Administration (FDA) has declined to grant at this time the Company’s request for Emergency Use Authorization (EUA) for sabizabulin, Veru’s novel microtubule disruptor, to treat hospitalized adult patients with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress Syndrome (ARDS). 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. Separately, the FDA also provided comments on a proposed confirmatory Phase 3 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 3 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. “Our team has applied its scientific rigor and clinical expertise to expeditiously investigate sabizabulin, a microtubule disruptor, for the treatment of hospitalized critically ill COVID-19 patients during the pandemic,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “We are disappointed in the FDA’s decision to decline the request for an EUA because of the possibility of unknown influences, or uncertainties that may have affected the study as FDA agreed upon its review that our Phase 3 study met its primary endpoint and could not be invalidated by any k...