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Veru Submits Emergency Use Authorization (EUA) Application to U.S. FDA for Sabizabulin, its Novel, Oral Antiviral and Anti-Inflammatory Drug Candidate for Hospitalized COVID-19 Patients at High Risk for ARDS
-- The EUA Submission Follows Positive Phase 3 COVID-19 Clinical Trial in which Sabizabulin Demonstrated a 55.2% Reduction in Death in Hospitalized COVID-19
About this update from Veru Inc.
[{"type":"text","content":"-- The EUA Submission Follows Positive Phase 3 COVID-19 Clinical Trial in which Sabizabulin Demonstrated a 55.2% Reduction in Death in Hospitalized COVID-19 Patients -- -- The Company is in Discussions with Other Regulatory Agencies Around the World Regarding Emergency Use Authorization for Sabizabulin Including the European Medicines Agency ---- Company Prepares for U.S. Commercial Launch if EUA is Granted -- MIAMI, June 07, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that is has submitted an emergency use authorization (EUA) application to the U.S. Food and Drug Administration for its sabizabulin 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 3 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 (≥ 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.“COVID-19 new cases and hospitalizations are on the rise again with a summer and fall-winter peaks expected. Unfortunately, the death rate in hospitalized patients with moderate to severe COVID-19 who are at risk for ARDS remains and will continue to be unacceptably high with current standard of care,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the...