Vertex Gets FDA Fast-Track Designation for VX-880 in Type 1 Diabetes
March 10 2021 - 7:52AM
Dow Jones News
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 08:37 ET (13:37 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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