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# Veru EUA Request for Covid Drug Denied
- URL: https://www.fdaweb.com/veru-eua-request-for-covid-drug-denied/
- Published: 2023-03-03T12:00:00.000Z
- Updated: 2026-09-14T18:18:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153899

FDA has declined a Veru request for an Emergency Use Authorization (EUA) for sabizabulin, a microtubule disruptor for treating hospitalized adult patients with moderate to severe Covid-19 who are at high risk for Acute Respiratory Distress Syndrome. In a statement, the company said the agency’s decision was based on “the possibility of unknown influences, or uncertainties that may have affected the study as FDA agreed upon its review that our Phase 3 study met its primary endpoint and could not be invalidated by any known influences, and we followed the unanimous recommendation of the Independent Data Monitoring Committee to stop the Phase 3 study because of clear clinical benefit.”

Late last year, FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 8 to 5 to recommend against the EUA, agreeing with agency concerns raised in a [briefing document](https://www.fda.gov/media/162979/download?ref=fdaweb.com) released before the meeting. In the document, FDA reviewers said that while the single study submitted by Veru met its prespecified primary endpoint of all-cause mortality at Day 60, they noted it was quite small in size (204 patients) compared to other therapeutic programs for patients hospitalized with Covid-19\. They said uncertainties with the trial data include high placebo group mortality rate, baseline imbalances in standard-of-care therapies, and differences in hospitalization duration before trial enrollment, among other issues.