Drugs for Inhalation Anthrax Will be Considered Under Animal Rule

The FDA released guidelines for developing drugs for prophylaxis of inhalational anthrax, saying applications will be reviewed through the Animal Rule pathway due to safety and ethical concerns about human trials.

The guidance focuses on prophylactic drugs indicated for individuals who have or may have inhaled aerosolized Bacillus anthracis spores but who are not yet showing symptoms, as well as individuals such as first-responders with anticipated exposure in an anthrax incident.

Developmental proposals “may be more convincing,” if the drug is shown to be safe and effective in the treatment of other relevant diseases, such as certain types of pneumonia, the agency said.