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ANDEMBRY (GARADACIMAB-GXII)
ANDEMBRY (generic name: GARADACIMAB-GXII) is a drug developed by CSL BEHRING LLC. It is currently FDA-approved for Prophylaxis for HAE.
Garadacimab-gxii inhibits activated FXII, reducing the activation of prekallikrein and bradykinin generation, thereby decreasing inflammation and swelling in HAE attacks.
Garadacimab-gxii (Andembyr) is a marketed prophylactic treatment for Hereditary Angioedema (HAE) developed by CSL Behring LLC, positioned to reduce inflammation and swelling during HAE attacks by inhibiting activated FXII. Its key strength lies in its mechanism of action, which effectively targets the activation of prekallikrein and bradykinin generation, providing a novel approach to managing HAE symptoms. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | GARADACIMAB-GXII |
|---|---|
| Sponsor | CSL BEHRING LLC |
| Target | activated Factor XII (FXIIa and βFXIIa) |
| Therapeutic area | Other |
| Phase | FDA-approved |
Mechanism of action
Garadacimab-gxii works by binding to and inhibiting the catalytic activity of activated Factor XII (FXIIa). This inhibition prevents the activation of prekallikrein to kallikrein and the subsequent production of bradykinin, which is a key mediator of inflammation and swelling in Hereditary Angioedema (HAE) attacks.
Approved indications
- Prophylaxis for HAE
Common side effects
- nasopharyngitis
- abdominal pain
Drug interactions
- ANDEMBRY (garadacimab-gxii)
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ANDEMBRY CI brief — competitive landscape report
- ANDEMBRY updates RSS · CI watch RSS
- CSL BEHRING LLC portfolio CI
Frequently asked questions about ANDEMBRY
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Related
- Target: All drugs targeting activated Factor XII (FXIIa and βFXIIa)
- Manufacturer: CSL BEHRING LLC — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Prophylaxis for HAE
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing