Table 6.

Postlicensure Study Metrics for the Evaluation of Anthrax Immunoglobulin Intravenous, Raxibacumab, and Obiltoxaximab in Rabbits Exposed to a Lethal Challenge

Phase	Arm	No.	% Male	Mean ± SD Weight, kg2	Mean ± SD Spore Challenge, LD50	Antitoxin		Nonsurvivors, Median Time to Death, h (min–max)	Survivors, n (Proportion)
						Dose	Route
1	AIGIV- Anthrasil	68	51	3.1 ± 0.24	230 ± 43	15 U/animal (4.7 mL/animal)	Slow IV infusion	110 (94–143)	15 (22)
1	Raxibacumab	68	51a	3.2 ± 0.28b	230 ± 46	40 mg/kg (4.7 mL/kg)	Slow IV infusion	(106, NC)	35 (51)
1	Placebo	12	30c	3.2 ± 0.33d	232 ± 48	4.7 mL/kg	Slow IV infusion	86 (47–107)	0 (0)
2	Raxibacumab	26	51a	3.2 ± 0.28b	195 ± 51	40 mg/kg (4.7 mL/kg)	Slow IV infusion	(77, NC)	15 (58)
2	Obiltoxaximab	68	53	3.3 ± 0.24	184 ± 56	16 mg/kg (4.7 mL/kg)	Slow IV infusion	(117, NC)	39 (57)
2	Placebo	8	30c	3.2 ± 0.33d	182 ± 65	4.7 mL/kg	Slow IV infusion	75 (56–106)	0 (0)

Abbreviations: AIGIV, anthrax immunoglobulin intravenous; IV, intravenous; LD₅₀, median lethal dose; SD, standard deviation; NC, not calculable.

^aPercentage male administered raxibacumab was only provided for phase 1 and 2 combined.

^bMean weight for rabbits administered raxibacumab was only provided for phase 1 and 2 combined.

^cPercentage male administered placebo was only provided for phase 1 and 2 combined.

^dMean weight for rabbits administered placebo was only provided for phase 1 and 2 combined.