Drug updated on 11/1/2024
| Dosage Form | Injection (intravenous; 1700 mg/34 mL [50 mg/mL]) |
| Drug Class | Monoclonal antibodies directed against the protective antigen of Bacillus anthracis |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult and pediatric patients with inhalational anthrax due to bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.
Latest News
Summary
- This summary is based on the review of one randomized controlled trial(s). [1]
- The primary outcome, geometric mean concentrations (GMCs) of anti-protective antigen antibodies 4 weeks after the first AVA (Anthrax Vaccine Adsorbed) dose, was 26.5 µg/mL (95% CI (confidence interval) 23.6-29.8) for the AVA group and 22.5 µg/mL (95% CI 20.1-25.1) for the AVA plus raxibacumab group, with a GMC ratio of 1.18 (90% CI 1.03-1.35; p=0.0019), meeting the non-inferiority margin.
- The co-administration of raxibacumab with AVA did not negatively impact AVA’s immunogenicity, as shown by comparable GMC levels between the AVA alone and AVA plus raxibacumab groups.
- The study population consisted of healthy volunteers aged 18-65 years with no prior exposure to protective antigen, with no specific effectiveness differences noted among subgroups.
- Adverse events were reported in 87 (30%) of 286 participants in the AVA group and 80 (29%) of 280 participants in the AVA plus raxibacumab group, with no significant differences between groups.
- No treatment-related serious adverse events were reported in either group.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Raxibacumab (raxibacumab) Prescribing Information. | 2021 | Emergent BioSolutions, Washington, DC |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Effect of raxibacumab on immunogenicity of Anthrax Vaccine Adsorbed: a phase 4, open-label, parallel-group, randomised non-inferiority study | 573Subjects F: 51% M: 49% | 2020 | The Lancet. Infectious Diseases |
Sex Distribution:
F:51%
M:49%
573Subjects
Year:
2020
Source:The Lancet. Infectious Diseases
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Virginia department of health anthrax: guidance for healthcare providers key medical and public health interventions after identification of a suspected case. | 2023 | Virginia Department of Health |