Veru Granted Expedited Provisional Registration Regulatory Pathway for Sabizabulin Treatment in Hospitalized COVID-19 Patients by Australia’s Therapeutic Goods AdministrationAugust 22, 2022 08:30 ET | Source: Veru Inc.
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MIAMI, Aug. 22, 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 Australia’s Therapeutic Goods Administration (TGA) has determined that sabizabulin treatment in hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS) qualifies for an expedited, provisional registration regulatory pathway.
A provisional registration determination by TGA is an expedited review of a provisional registration application, whose application, if authorized, would allow the drug to be prescribed in Australia earlier than the standard registration process. Veru’s regulatory agent in Australia is Adjutor Healthcare Pty Ltd.
“We are pleased that another tier 1 regulatory agency, Australia’s Therapeutics Goods Administration, has determined that sabizabulin qualifies for an expedited regulatory review pathway for the treatment of hospitalized COVID-19 patients at high risk for ARDS,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “In addition to the Australian TGA, we now are in the process of seeking emergency use authorizations or expedited reviews by the United States FDA, the European Union EMA, and the United Kingdom MHRA. It is currently winter in Australia and the COVID death rate in Australia in hospitalized COVID-19 patients who are at risk for ARDS remains unacceptably high with current standard of care. By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19 infections.” |
