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The biopharmaceutical company Veru Inc. announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has agreed to support an expedited review of the marketing authorization for its product, sabizabulin, when the application is submitted. This is based on currently available data on the use of sabizabulin in the treatment of hospitalised COVID-19 patients at high risk for Acute Respiratory Distress. A phase 3 study conducted in patients admitted to hospital with COVID-19 was unanimously halted before completion by the Data Monitoring Committee, due to its "overwhelming safety and efficacy".
The company submitted a request to the US Food and Drug Administration in June 2022 for emergency use authorisation.
Sabizabulin is an oral treatment for hospitalised patients with moderate to severe COVID-19 at high risk for acute respiratory distress syndrome. It is a new class of medicine, a "microtubule disruptor", that has anti-inflammatory and antiviral properties.
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