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Defitelio, defibrotide

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Company Jazz Pharmaceuticals plc
DescriptionSingle-stranded oligodeoxyribonucleotides derived from porcine mucosal DNA
Molecular Target Cathepsin G
Mechanism of ActionCathepsin G inhibitor
Therapeutic ModalityNucleic acid: Linear DNA
Latest Stage of DevelopmentMarketed
Standard IndicationLiver disease
Indication DetailsPrevent hepatic veno-occlusive disease (VOD); Prevent pediatric veno-occlusive disease (VOD); Prevent veno-occlusive disease (VOD) in adults; Treat and prevent hepatic veno-occlusive disease (VOD); Treat and prevent hepatic veno-occlusive disease (VOD) in hematopoietic stem-cell transplantation therapy in adults and children; Treat hepatic veno-occlusive disease (VOD) in hematopoietic stem-cell transplantation therapy in adults and children; Treat pediatric veno-occlusive disease (VOD); Treat severe veno-occlusive disease (VOD); Treat veno-occlusive disease (VOD)
Regulatory Designation

U.S. - Expanded Access (Treat severe veno-occlusive disease (VOD));
U.S. - Fast Track (Prevent hepatic veno-occlusive disease (VOD));
U.S. - Orphan Drug (Treat and prevent hepatic veno-occlusive disease (VOD));
EU - Orphan Drug (Treat and prevent hepatic veno-occlusive disease (VOD));
EU - Standard Review (Treat and prevent hepatic veno-occlusive disease (VOD) in hematopoietic stem-cell transplantation therapy in adults and children);
Australia - Orphan Drug (Treat severe veno-occlusive disease (VOD))

Partner

Link Healthcare; Valeant Pharmaceuticals International Inc.


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