Veru Submits EUA for Treatment of COVID-19 Hospitalized Patients

Veru submitted an Emergency Use Authorization (EUA) application to the FDA for its investigational oral drug candidate sabizabulin for the treatment of moderate-to-severe hospitalized COVID-19 patients who are at high risk of developing Acute Respiratory Distress Syndrome (ARDS).

ARDS, which is common in severe COVID-19 infections, occurs when fluid builds up in the lungs, causing severe shortness of breath.

In a late-stage clinical trial that enrolled 204 hospitalized participants, the dual anti-inflammatory and antiviral drug demonstrated a 55.2 percent reduction in deaths relative to the untreated cohort.

The Independent Data Monitoring Committee halted the study due to the drug’s overwhelming efficacy.