“Drug safety assessed in human volunteers and in a battery of nonclinical studies in healthy rabbits and non-human primates showed no evidence of toxicity at the maximum proposed, single therapeutic dose of intravenous raxibacumab to be administered to human adults of 40 mg/kg.”
✓ VerifiedFDA pharmacology/toxicology review, p. 6Source ↗
Why that species
Target is a bacterial toxin; rabbit and cynomolgus macaque are the inhalation anthrax efficacy models
“several drug efficacy studies of raxibacumab with and without antibiotic in inhalation anthrax animal models (NZW rabbit and cynomolgus macaque)”
✓ VerifiedFDA pharmacology/toxicology review, p. 6Source ↗
Surrogate molecule
No surrogate; the clinical antibody was tested in cynomolgus monkeys and rabbits
“Healthy cynomolgus macaques administered 3 intravenous doses or 3 subcutaneous doses of 40 mg/kg raxibacumab once every 12 days”