TAKHZYRO
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
- 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
Drugs Similar to TAKHZYRO
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
TAKHZYRO FDA Label Details
ProIndications & Usage
FDA Label (PDF)TAKHZYRO ® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older. TAKHZYRO is a plasma kallikrein inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 2 years and older.
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.