Aldagen Obtains Orphan Drug Designation for Blood Transplant Drug
Aldagen, a biopharmaceutical company, has received orphan drug designation for ALD-101 from the FDA. The designation was granted for the use of ALD-101 to improve patient outcomes by decreasing time to platelet and neutrophil engraftment in patients with inherited metabolic disorders undergoing umbilical cord blood transplantation.
Aldagen is currently conducting a Phase III trial infusing ALD-101 in patients with inherited metabolic disorders undergoing umbilical cord blood transplantation.
Cord blood transplantation is commonly used to treat children with inherited metabolic diseases, including Krabbe syndrome, metachromatic leukodystrophy, Hurler syndrome and adrenoleukodystrophy.
Tom Amick, chairman and CEO of Aldagen, said: “FDA orphan drug designation for ALD-101 is an important asset in Aldagen’s development of ALD-101. We are encouraged by the reductions in engraftment times seen in the Phase I ALD-101 trial and look forward to continuing our on-going Phase III trial of ALD-101.”