TAKHZYRO (lanadelumab-flyo)
TAKHZYRO (lanadelumab-flyo) is a plasma kallikrein inhibitor indicated for the prevention of hereditary angioedema (HAE) attacks. It is approved for use as a prophylactic treatment in both adult and pediatric patients aged 2 years and older. The medication provides a preventative therapeutic approach for individuals who experience the swelling and pain characteristic of HAE.
How TAKHZYRO Works
Lanadelumab-flyo is a monoclonal antibody that binds to plasma kallikrein and inhibits its proteolytic activity. In patients with HAE, the lack of normal regulation leads to uncontrolled plasma kallikrein activity, which cleaves high-molecular-weight-kininogen to produce excess bradykinin. By decreasing this activity, the drug controls the generation of bradykinin, a vasodilator responsible for the increased vascular permeability and swelling seen in HAE attacks.
Details
- Status
- Prescription
- First Approved
- 2018-08-23
- Patent Cliff
- 2030
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
TAKHZYRO Approval History
What TAKHZYRO Treats
1 indicationsTAKHZYRO is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hereditary Angioedema
TAKHZYRO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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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Active Pipeline
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Key Completed Trials
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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.
TAKHZYRO FDA Label Details
Indications & Usage
FDA Label (PDF)TAKHZYRO is indicated for the treatment of Hereditary Angioedema.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.