An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

In this section: Vaccines, Blood & Biologics

ZYNTEGLO

STN: 125717
Proper Name: betibeglogene autotemcel
Tradename: ZYNTEGLO
Manufacturer: bluebird bio Inc.
Indication:

For treatment of adult and pediatric patients with ß-thalassemia who require regular red blood cell (RBC) transfusions

Product Information

Package Insert - ZYNTEGLO
Demographic Subgroup Information – betibeglogene autotemcel [ZYNTEGLO]
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

Supporting Documents

Related Information

FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients with Beta-thalassemia Who Require Regular Blood Transfusions

Top