> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Jazz NDA for Liver Condition After Stem Cell Transplant
- URL: https://www.fdaweb.com/jazz-nda-for-liver-condition-after-stem-cell-transplant/
- Published: 2016-03-30T12:00:00.000Z
- Updated: 2026-09-14T20:51:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135233

> FDA has approved a Jazz Pharmaceuticals NDA for Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after receiving a hematopoietic stem cell transplantation (HSCT). Hepatic VOD can occur in patients who receive chemotherapy and HSCT, according to an agency [news release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm493225.htm?ref=fdaweb.com). It is characteristic of veins in the liver becoming blocked, causing swelling and a decrease in blood flow, which may lead to liver damage.  
>  
> Approval was based on data from 528 patients treated in three studies — two prospective clinical trials and an expanded access study. “In the three studies, 38 to 45% of patients treated with Defitelio were alive 100 days after HSCT,” FDA says. “Based on published reports and analyses of patient-level data, the expected survival rates 100 days after HSCT would be 21 to 31% for patients with severe hepatic VOD who received only supportive care or interventions other than Defitelio.