ADAKVEO
Adakveo (crizanlizumab-tmca) is a selectin blocker indicated to reduce the frequency of vaso-occlusive crises in patients with sickle cell disease. The therapy is approved for use in adults and pediatric patients aged 16 years and older. It serves a therapeutic role by targeting the underlying cellular adhesion processes that contribute to these complications.
How ADAKVEO Works
Crizanlizumab-tmca is a humanized monoclonal antibody that binds to P-selectin and blocks its interaction with ligands such as P-selectin glycoprotein ligand 1. By binding to P-selectin on the surface of activated platelets and endothelial cells, the drug prevents these cells from interacting with red blood cells and leukocytes. It can also dissociate preformed complexes between P-selectin and its ligands. This inhibition of cellular adhesion helps manage the biological interactions that lead to vaso-occlusive crises.
Details
- Status
- Prescription
- First Approved
- 2019-11-15
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ADAKVEO Approval History
What ADAKVEO Treats
1 indicationsADAKVEO is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Sickle Cell Disease
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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.
ADAKVEO FDA Label Details
ProIndications & Usage
FDA Label (PDF)ADAKVEO ® is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease. ADAKVEO is a selectin blocker indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.