ICATIBANT ACETATE · Fresenius Kabi
Icatibant acetate helps adults 18 years and older manage sudden episodes of hereditary angioedema. It treats the symptoms of these acute attacks, which typically include localized swelling, inflammation, and pain. This medication provides a targeted option for patients experiencing the physical distress associated with this genetic condition.
How ICATIBANT ACETATE Works
This medication works by selectively blocking the B2 receptor, which prevents the peptide bradykinin from binding to it. Since bradykinin acts as a vasodilator responsible for the swelling and pain seen in hereditary angioedema, inhibiting its activity helps stop the inflammatory process. This action effectively addresses the clinical symptoms during an acute, episodic attack.
Details
- Status
- Prescription
- First Approved
- 2011-08-25
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
Companies
ICATIBANT ACETATE Approval History
What ICATIBANT ACETATE Treats
1 indicationsICATIBANT ACETATE is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hereditary Angioedema
ICATIBANT ACETATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Fresenius Kabi's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
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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.
ICATIBANT ACETATE FDA Label Details
Indications & Usage
Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Icatibant injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.