ANTHIM
ANTHIM (obiltoxaximab) is a monoclonal antibody indicated for the treatment of inhalational anthrax in adult and pediatric patients, administered in combination with appropriate antibacterial drugs. It is also indicated for prophylaxis when alternative therapies are unavailable or inappropriate, provided the benefits outweigh the risks of hypersensitivity and anaphylaxis. Because human efficacy trials involving intentional exposure are unethical, the drug's effectiveness is based on animal models, and it is not expected to cross the blood-brain barrier to treat meningitis.
How ANTHIM Works
Obiltoxaximab is a monoclonal antibody that specifically binds to the protective antigen (PA) of Bacillus anthracis. By binding to this target, the drug neutralizes the biological activity of the anthrax toxin. It does not possess direct antibacterial activity and is intended for use alongside appropriate antibacterial medications to manage the infection.
Details
- Status
- Prescription
- First Approved
- 2016-03-18
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ANTHIM Approval History
What ANTHIM Treats
1 indicationsANTHIM is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inhalational Anthrax
ANTHIM Boxed Warning
HYPERSENSITIVITY and ANAPHYLAXIS Hypersensitivity and anaphylaxis have been reported during the intravenous infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and tr...
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS Hypersensitivity and anaphylaxis have been reported during the intravenous infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs [see Indications and Usage ( 1.2 ), Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.1 )]. WARNING: HYPERSENSITIVITY and ANAPHYLAXIS See full prescribing information for complete boxed warning. Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion ( 5.1 ) ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis ( 1.2 , 2.4 , 5.1 ) Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs ( 2.4 , 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.
ANTHIM FDA Label Details
ProIndications & Usage
FDA Label (PDF)ANTHIM ® is a monoclonal antibody directed against the protective antigen of Bacillus anthracis . It is indicated in adult and pediatric patients for treatment of inhalational anthrax due to B. 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 ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. The effectiveness of ANTHIM is based solely on efficacy ...
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS Hypersensitivity and anaphylaxis have been reported during the intravenous infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. M...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.