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# Vertex Gets Fast Track for Diabetes Cell Therapy
- URL: https://www.fdaweb.com/vertex-gets-fast-track-for-diabetes-cell-therapy/
- Published: 2021-03-10T12:00:00.000Z
- Updated: 2026-09-14T16:50:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148848

FDA has granted Vertex Pharmaceuticals a fast track designation for VX-880 for treating patients who have Type 1 diabetes with severe hypoglycemia and impaired hypoglycemic awareness. The company says the first clinical trial sites at the University of Miami Health System, the University of Pennsylvania and Massachusetts General Hospital are open for enrollment, and additional sites will be activated this year to evaluate the therapy. The VX-880 trial will involve an infusion of fully differentiated, functional islet cells, as well as the chronic administration of concomitant immunosuppressive therapy, to protect the islet cells from immune rejection. VX-880, formerly known as STx-02, is described as an investigational allogeneic human stem cell-derived islet cell therapy that has the potential to restore the body’s ability to regulate glucose levels by restoring pancreatic islet cell function, including insulin production.