BRIEF⁠—MHRA agrees to review Veru's submission for sabizabulin

Veru has announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) regards the currently available safety and efficacy data as sufficient to support an expedited review of the marketing authorization application for using sabizabulin in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS) when the application is submitted.

Mitchell Steiner, chairman, president, and chief executive of Veru, said: “With this decision, we plan to proceed toward the submission of our application as soon as possible.

“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.”