- Clinical-stage biotech Veru ( NASDAQ: VERU ) announced on Monday that U.K. regulators agreed that the currently available safety and efficacy data for its experimental COVID-19 therapy sabizabulin would support an expedited review for a marketing application.
- The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued this view in relation to a potential marketing authorization application for the oral drug in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS).
- “With this decision, we plan to proceed toward the submission of our application as soon as possible,” Veru’s ( VERU ) Chief Executive Officer Mitchell Steiner noted.
- In June, the company announced it sought the FDA’s emergency use authorization for sabizabulin as a treatment for hospitalized COVID-19 patients who are at risk of ARDS.
For further details see:
Veru eligible for expedited review in U.K. for COVID-19 therapy