Veru (VERU) Announce UK’s MHRA Supports Expedited Review of MAA for Sabizabulin Treatment in Hospitalized COVID-19 Patients
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 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.
“We are pleased that the MHRA has agreed to support the expedited review of our sabizabulin UK marketing authorization submission. With this decision, we plan to proceed toward the submission of our application as soon as possible,” said 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.”