FDA Schedules Adcomm For Veru's Cancer Drug Repurposed For COVID-19

  • The FDA is convening an adcomm meeting of its Pulmonary-Allergy Drugs Advisory Committee, slated for October 6, to discuss Veru Inc's VERU request for Emergency Use Authorization of sabizabulin for hospitalized COVID-19 patients at high risk for ARDS. 
  • In a public notice, the FDA said that as part of the adcomm, one of the focuses of the experts will include "the treatment effect size in the context of the high placebo mortality rate, the limited size of the safety database, and identifying the proposed population."
  • Veru had filed a EUA request to the FDA in June for its candidate sabizabulin to treat moderate to severe Covid-19 infection in patients at high risk for "acute respiratory distress syndrome."
  • At the time, the biotech said in a pre-EUA meeting with the FDA that the regulatory agency agreed that it had enough data to support both a EUA and marketing application submission for the drug candidate.
  • Veru's candidate was shown to reduce the relative risk of death from Covid-19 by 55%. 
  • In July, The UK's regulatory agency said the sabizabulin marketing application would receive expedited review, and European Medicines Agency's Emergency Task Force initiated the review of sabizabulin.
  • Price Action: VERU shares are down 0.87% at $11.41 during the premarket session on the last check Thursday.
Posted In: BiotechNewsHealth CareSmall CapFDAMoversTrading IdeasGeneralBriefsCOVID-19 Coronavirus
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