Not over yet since the FDA May allow with some provisions. Adcom an advisory and not a final decision. Let’s see what happens since I believe as the Wednesday company PR states:
Veru Provides Update on FDA Advisory Committee Meeting Regarding Emergency Use Authorization of Sabizabulin to Treat Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome
MIAMI, FL, Nov. 09, 2022 (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, announces the results of today’s meeting of the U.S. Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC), which reviewed sabizabulin for Emergency Use Authorization (EUA) in hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome (ARDS). The advisory committee voted 8-5 that the known and potential benefits of sabizabulin when used for the treatment of adult patients hospitalized with COVID-19 at high risk of ARDS do not outweigh the known and potential risks of sabizabulin. However, there was additional discussion around the clinical trial design aspects of an additional clinical trial as a potential post authorization requirement. FDA will consider the input of the advisory committee as part of their review of the EUA and render a decision on the Emergency Use Authorization.
“We look forward to continuing to work with the FDA as we continue our efforts to ensure that this product is available to patients in a timely manner,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru.
“In a still evolving COVID-19 pandemic taking the lives of over 300 U.S. citizens a day and with the threat of new virus variants looming that may not be as easily treated with the limited array of presently used therapies, there is an urgent need for newer therapies with much greater effectiveness than what is available. Sabizabulin with its unique action as a microtubular disruptor, both reducing inflammation and viral replication independent of virus variant, shows compelling promise,” said Erik Swenson, M.D. Professor of Medicine, Physiology, and Biophysics, University of Washington, and former Chairman of PADAC. “In a recently published well-executed double-blind placebo-controlled trial of patients with respiratory compromise and at high risk of developing ARDS, sabizabulin reduced absolute mortality at 60 days by 20.5%, compared to 0-6% for all other available drugs. In the long history of drug trials for patients with severe respiratory failure over many decades, there has never been a drug to show such dramatic protection.”
“Adding sabizabulin to the cadre of therapies among hospitalized patients with COVID-19 is crucial in the effort to reduce mortality among a group of patients who have seen the least reduction in death despite newer treatments and approaches,” said Christian Sandrock, M.D. Division Vice Chief of Internal Medicine and Director of Critical Care University of California, Davis, School of Medicine.
Phase 3 sabizabulin clinical study:
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-19 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 the full study, there were 204 patients enrolled, and for the primary endpoint, there was a clinically meaningful and statistically significant 20.5% absolute reduction and 51.6% relative reduction in mortality at Day 60. 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®.
Global regulatory activities:
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) informed the Company on July 25, 2022, that the sabizabulin marketing authorization application will receive expedited review. On July 27, 2022, The European Medicines Agency’s Emergency Task Force initiated the review of sabizabulin treatment for hospitalized COVID-19 patients for emergency use in European Union countries. On August 22, 2022, Australia’s Therapeutic Goods Administration (TGA) determined that sabizabulin treatment in hospitalized COVID-19 patients at high risk for ARDS qualifies for an expedited, provisional registration regulatory pathway.
