FDA Brief: Week of Feb 15, 2016

• Assist sponsors in the development of drugs for prophylaxis of inhalational anthrax
  • inhaled aerosolized Bacillus 21 anthracis spores but who have not yet manifested clinical evidence of disease
  • probable imminent exposure to anthracis spores

• Consider approved antibacterial drugs for other indications marketed for many years, and have safety information from millions of patients before approval for inhalational anthrax

• Approval based on Animal Rule regulations as definitive human efficacy studies cannot be conducted; Rely on evidence from animal studies to provide substantial evidence of effectiveness

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• Help sponsors determine amount and type of safety data to collect during late-stage premarket and postapproval clinical investigations

• Selective approach based on known drug safety profile

• Balance eliminating data collection that will not be useful vs. collecting sufficient data to allow adequate characterization of safety profile

• Consult with the relevant FDA review division on appropriate strategy

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