Drug updated on 4/17/2024
| Dosage Form | Injection (intravenous; 1700 mg/34 mL [50 mg/mL]) |
| Drug Class | Monoclonal antibody against B. 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.
Summary
- Raxibacumab is indicated for the treatment and prophylaxis of inhalational anthrax due to Bacillus anthracis in both adult and pediatric patients, used in combination with appropriate antibacterial drugs. It is also an alternative when other therapies are not available or suitable.
- The study focused on FDA-approved anthrax antitoxins, including Raxibacumab, in a systematic review/meta-analysis context.
- All three FDA-approved anthrax antitoxins, including Raxibacumab, demonstrated significant improvement in survival as monotherapy over placebo in preclinical models involving rabbits and non-human primates.
- There was no significant improvement found when combining an antitoxin like Raxibacumab with antimicrobial therapy compared to using antimicrobial therapy alone. This suggests that while useful under certain circumstances, the role of such antitoxins should be carefully considered alongside traditional treatments.
- Case studies of 25 patients treated with these types of antitoxins for systemic anthrax disease were reported; 17 survived. However, due to the small sample size and lack of a control group, it is difficult to directly compare the effectiveness among different options, including Raxibacumab.
- For post-exposure prophylaxis (PEP), animal studies indicated that monotherapy using any one among the approved antitoxins significantly improved survival rates over placebo, especially if administered early after exposure.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Raxibacumab Prescribing Information. | 2021 | Emergent BioSolutions Inc., Gaithersburg, MD |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Antitoxin use in the prevention and treatment of anthrax disease: a systematic review. | 2022 | Clinical 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 |
| Analysis of the clinical pipeline of treatments for drug-resistant bacterial infections: despite progress, more action is needed. | 2022 | Antimicrobial Agents and Chemotherapy |
| Extrapolation and dosing recommendations for raxibacumab in children from birth to age <18 years | 2021 | British Journal of Clinical Pharmacology |