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# FDA Raises Sabizabulin ‘Uncertainties’
- URL: https://www.fdaweb.com/fda-raises-sabizabulin-uncertainties/
- Published: 2022-11-08T12:00:00.000Z
- Updated: 2026-09-14T18:05:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153149

In advance of an 11/9 meeting of the FDA Pulmonary-Allergy Drugs Advisory Committee, FDA medical reviewers are raising several “uncertainties” about a Veru request for an emergency use authorization for its investigational prostate cancer drug VERU-111 (sabizabulin) as a treatment for hospitalized adults with moderate to severe Covid-19 who are at high risk for acute respiratory distress syndrome. The reviewers aired their concerns in a [briefing document](https://www.fda.gov/media/162979/download?ref=fdaweb.com) released before the meeting.

The paper says the reviewers acknowledge that the single study submitted by Veru met its prespecified primary endpoint of all-cause mortality at Day 60\. They also noted that the study was quite small in size (204 patients) compared to other therapeutic programs for patients hospitalized with Covid-19.

The reviewers say the uncertainties with the trial data include:

- high placebo group mortality rate;
- potential for unblinding events with enteral tube administration;
- baseline imbalances in standard-of-care therapies;
- differences in hospitalization duration before trial enrollment;
- uncertain effects of goals of care decisions on all-cause mortality;
- negative studies with other microtubule disruptors in Covid-19; and
- uncertainty in the identification of a clinically relevant patient population.

The agency is asking the advisory committee to:

- discuss the all-cause mortality data and specifically address the extent to which the data could have been affected by the uncertainties raised by the reviewers;
- discuss the level of concern with the limited size of the safety database for this new molecular entity; and
- consider whether the known and potential benefits of VERU-111 when used to treat specific Covid-10 adult patients outweigh the known and potential risks.