The oncology biopharma Veru (Nasdaq: VERU) has announced that the FDA has moved the date for its Pulmonary-Allergy Drugs Advisory Committee to discuss the potential emergency use authorization (EUA) of sabizabulin for hospitalized COVID-19 patients.
The meeting is now slated for November 9, 2022.
It was originally scheduled for October 6, 2022.
VERU shares skidded almost 15% to $12.15 in early afternoon trading.
In particular, the Miami-based company aims to obtain EUA or COVID-19 patients with an elevated risk of developing acute respiratory distress syndrome (ARDS).
In April, the company shared positive efficacy and safety data from an interim analysis of a Phase 3 study evaluating oral sabizabulin 9 mg against a placebo.
The company halted the study after an independent data monitoring committee unanimously recommended doing so.
The primary endpoint for the drug was reducing the proportion of deaths by Day 60.
The committee concluded that sabizabulin effectively reduced deaths based on a planned interim analysis involving 150 randomized patients. In the placebo-controlled study, sabizabulin led to a 55.2% relative death reduction.
The company also concluded there were no safety concerns.
The FDA advisory committee plans to discuss the treatment effect size, including the high placebo mortality rate. It will also consider the limited scope of the safety database and discuss the proposed COVID-19–related population for sabizabulin.
The study involved 204 hospitalized COVID-19 patients with moderate to severe COVID-19 infections facing a high risk for ARDS and death.
Sabizabulin is a tubulin inhibitor. It has anti-inflammatory and antiviral properties.
Veru announced that data from the study would be published in The New England Journal of Medicine Evidence.
In the United Kingdom and Australia, sabizabulin’s marketing authorization application has received expedited review.
The European Medicines Agency’s Emergency Task Force announced on July 27 that it would be reviewing an application for emergency use in the European Union.
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