- The FDA declined to grant Veru Inc's VERU request for Emergency Use Authorization (EUA) for sabizabulin to treat hospitalized adult patients with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress Syndrome (ARDS).
- Separately, the FDA also commented on the company's proposed confirmatory Phase 3 study protocol for hospitalized moderate to severe COVID-19 patients at risk for ARDS and death that could support a new EUA authorization and/or NDA approval.
- Also See: Biden Administration Plans To End COVID-19 Public Health Emergency In May.
- FDA stated that in the potential confirmatory Phase 3 study design: "strong consideration should be given to appropriate time frames for interim analyses so that – should a strong efficacy signal again be observed – the trial could be stopped in an efficient time frame."
- Veru expects to communicate the details of the design and timing of this potential Phase 3 confirmatory study soon.
- In May 2022, pre-EUA meeting with the FDA, the agency indicated that our clinical data package was sufficient to support a EUA submission.
- In November, as per the briefing documents, the FDA had spelled out its concerns with the pivotal data that Veru submitted.
- It acknowledged that sabizabulin hit the mark on mortality in the small trial but noted uncertainties or imbalances that, while not problematic individually, "raise questions about the results."
- Price Action: VERU shares are down 36.7% at $2.39 during the premarket session on the last check Friday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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