MHRA will support expedited review ofsabizabulin treatment in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome
Veru Inc. announced that the United Kingdom’s (UK’s) Medicines and Healthcare Products Regulatory Agency (MHRA) considers that the currently available safety and efficacy data will support an expedited review of the marketing authorization application for the Company’s sabizabulin treatment in hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS) when the application is submitted
Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “COVID infections are sharply rising in the UK. Unfortunately, the death rate in hospitalized patients with moderate to severe COVID-19 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 in the UK and elsewhere.”