DJ Vertex Gets FDA Fast-Track Designation for VX-880 in Type 1 Diabetes >VRTX
By Colin Kellaher
Vertex Pharmaceuticals Inc. Wednesday said the U.S. Food and Drug Administration granted fast-track designation to VX-880 for patients who have type 1 diabetes with severe hypoglycemia and impaired hypoglycemic awareness.
The Boston drug maker said it has launched a Phase 1/2 clinical trial of VX-880, an investigational allogeneic human stem cell-derived islet cell therapy that it believes has the potential to restore the body's ability to regulate glucose levels by restoring pancreatic islet cell function, including insulin production.
The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.
Vertex said VX-880 is the first and only pancreatic islet replacement therapy known to receive the designation.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 10, 2021 08:22 ET (13:22 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.