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Veru Announces FDA has Updated the Meeting Date for the 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 with Same Agenda Has Been Rescheduled to November 09, 2022-- MIAMI, Sept. 19, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU),
About this update from Veru Inc.
[{"type":"text","content":"--Advisory Committee Meeting with Same Agenda Has Been Rescheduled to November 09, 2022--\nMIAMI, Sept. 19, 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 of an updated meeting date for the FDA’s Pulmonary-Allergy Drugs Advisory Committee to discuss the Company’s request for Emergency Use Authorization of sabizabulin for hospitalized COVID-19 patients who are at high risk for ARDS. Although the meeting has been rescheduled to November 09, 2022, the agenda has not changed according to the notification published in the Federal Register. 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 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 reduction in deaths compared to placebo. In June, the Company submitted a request for emergency use authorization to FDA. On July 6, 2022, the Company announced the publication of the Phase 3 COVID-19 trial results evaluating the efficacy and safety of oral sabizabulin in The New England Journal of Medicine Evidence®. The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) informed the Company on July 25, 2022, that the sabizabulin market...