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Veru Announces Date for FDA Advisory Committee Meeting to Review Emergency Use Authorization for Sabizabulin for Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome
—Advisory Committee Meeting Scheduled for October 06, 2022— MIAMI, Sept. 07, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company
About this update from Veru Inc.
[{"type":"text","content":"—Advisory Committee Meeting Scheduled for October 06, 2022—\nMIAMI, Sept. 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 the U.S. Food and Drug Administration (FDA) has informed the Company that FDA’s Pulmonary-Allergy Drugs Advisory Committee will meet to discuss the Company’s request for Emergency Use Authorization of sabizabulin for hospitalized COVID-19 patients at high risk for ARDS. The meeting is scheduled for October 06, 2022. “The FDA has now completed the audits of selected Phase 3 clinical sites in the United States and now Brazil and Bulgaria and no deficiencies were reported to us. The FDA informed us today that they intend to convene an Advisory Committee Meeting to discuss the emergency use authorization for sabizabulin,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “We are looking forward to advancing the regulatory review process for the use of sabizabulin for the treatment of hospitalized moderate to severe COVID-19 patients at high risk for ARDS.” About Veru Inc.Veru is 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. Infectious disease program: The Company has completed a positive Phase 3 COVID-19 study evaluating sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS. A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in 204 hospitalized COVID-19 patients with moderate to severe COVID (≥ WHO 4-supplemental oxygen) at high risk for ARDS and death. The primary 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 clear clinical efficacy and no safety concerns were identified. Treatment with sabizabulin 9 mg once daily, an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55.2% relative reducti...