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Anthim (OBILTOXAXIMAB)
Anthim works by binding to the protective antigen of anthrax toxin, neutralizing its effects.
Anthim (obiltoxaximab) is a monoclonal antibody developed by Elusys Therapeutics Inc, targeting inhalational anthrax. It works by binding to the protective antigen of anthrax toxin, thereby neutralizing its effects. Anthim is a patented, anthrax protective antigen-directed antibody, approved by the FDA in 2016. It is used to treat inhalational anthrax, a potentially life-threatening condition caused by exposure to anthrax spores. Key safety considerations include potential allergic reactions and the need for careful administration.
At a glance
| Generic name | OBILTOXAXIMAB |
|---|---|
| Sponsor | Elusys Therapeutics Inc |
| Drug class | Anthrax Protective Antigen-directed Antibody [EPC] |
| Modality | Monoclonal antibody |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2016 |
Mechanism of action
Obiltoxaximab is monoclonal antibody that binds the PA of B. anthracis [see Microbiology (12.4)].
Approved indications
- Inhalational anthrax
Boxed warnings
- 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 )
Common side effects
- Headache
- Infusion site swelling
- Cough
- Vessel puncture site bruise
- Infusion site pain
- Urticaria
- Pain in extremity
- Nasal congestion
- Pruritus
- Infections of the upper respiratory tract
- Infusion site erythema
- Rhinorrhea
Key clinical trials
- An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis (PHASE4)
- Safety, Tolerability and PK of Repeat Administration of Intravenous ETI-204 in Adult Volunteers (PHASE1)
- Intramuscular Dose-Escalation Study With ETI-204 in Adult Volunteers (PHASE1)
- Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers (PHASE1)
- Safety, Tolerability, and PK of a Single Intravenous Dose of ETI-204 in Adult Volunteers (PHASE1)
- Intravenous Dose-Escalation Study With ETI-204 in Adult Volunteers (PHASE1)
- Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers (PHASE1)
- Monoclonal Antibody for Treatment of Inhalation Anthrax (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Anthim CI brief — competitive landscape report
- Anthim updates RSS · CI watch RSS
- Elusys Therapeutics Inc portfolio CI