NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Mar 2016
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
5/8 — Partial
Priority Review
DEFITELIO (defibrotide sodium) by Jazz Pharmaceuticals is elucidated. Approved for known, renal, pulmonary dysfunction following hematopoietic stem-cell transplantation (hsct). First approved in 2016.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DEFITELIO (defibrotide sodium) is an intravenous fibrinolytic agent approved for treatment of hepatic veno-occlusive disease (VOD) with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation. It enhances plasmin activity to dissolve fibrin clots and protects endothelial cells from chemotherapy and inflammatory damage. The drug works by increasing tissue plasminogen activator and thrombomodulin expression while reducing pro-thrombotic factors.
Peak6.1 years to LOE
Product is in peak commercial phase with established market presence; team size and growth trajectory are dependent on Jazz Pharmaceuticals' strategic allocation to this orphan/rare disease indication.
Mechanism of Action
elucidated. In vitro , defibrotide sodium enhances the enzymatic activity of plasmin to hydrolyze fibrin clots. Studies evaluating the pharmacological effects of defibrotide sodium on endothelial cells (ECs) were conducted primarily in the human microvascular endothelial cell line. In vitro ,…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.