RAXIBACUMAB
Raxibacumab is an anthrax protective antigen-directed antibody indicated for the treatment of inhalational anthrax due to Bacillus anthracis in adult and pediatric patients. It is administered in combination with appropriate antibacterial drugs and may also be used for prophylaxis when alternative therapies are not available or appropriate. Because human clinical trials involving intentional exposure to anthrax are unethical, the drug's effectiveness was established using animal models. The medication does not cross the blood-brain barrier and is not indicated for the treatment or prevention of meningitis.
How RAXIBACUMAB Works
Raxibacumab is a monoclonal antibody that specifically binds to the protective antigen (PA) of Bacillus anthracis. By targeting this antigen, the drug neutralizes the toxins produced by the bacteria to prevent their harmful effects. Raxibacumab does not have direct antibacterial activity and must be used in conjunction with antibacterial drugs to address the underlying infection.
Details
- Status
- Prescription
- First Approved
- 2012-12-14
- Routes
- IV (INFUSION)
- Dosage Forms
- INJECTABLE
RAXIBACUMAB Approval History
What RAXIBACUMAB Treats
1 indicationsRAXIBACUMAB is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inhalational Anthrax
RAXIBACUMAB Boxed Warning
HYPERSENSITIVITY and ANAPHYLAXIS Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion [see Warnings and Precautions ( 5.1 )] . Administer raxibacumab by intravenous infusion in monitored settings where appropriate equipment, medication (including epinephrine) and personnel trained in the management of hypersensitivity, anaphylaxis, and shock are available [see Warnings and Precautions ( 2.3 , 5.1 )] . WARN...
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion [see Warnings and Precautions ( 5.1 )] . Administer raxibacumab by intravenous infusion in monitored settings where appropriate equipment, medication (including epinephrine) and personnel trained in the management of hypersensitivity, anaphylaxis, and shock are available [see Warnings and Precautions ( 2.3 , 5.1 )] . WARNING: HYPERSENSITIVITY and ANAPHYLAXIS See full prescribing information for complete boxed warning Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion ( 5.1 ). Administer raxibacumab by intravenous infusion in monitored settings where appropriate equipment, medication (including epinephrine) and personnel trained in the management of hypersensitivity, anaphylaxis, and shock are available ( 2.3 , 5.1 ).
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RAXIBACUMAB FDA Label Details
ProIndications & Usage
FDA Label (PDF)Raxibacumab is 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. Limitations of Use: The effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of raxibacumab in the pediatric population. Dosing in pediatric patients was derived using an extrapolation approach. Raxibacumab does not cross the ...
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion [see Warnings and Precautions ( 5.1 )] . Administer raxibacumab by intravenous infusion in monitored settings wher...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.