The Food and Drug Administration awarded the University of Cincinnati a $2.7 million grant to conduct a study on drugs that restrict activity in the immune system.
The study aims to end questions concerning the differences between generic and brand-name versions of tacrolimus, common immunosuppressive drugs, used to help post-transplant patients accept their new organs.
“The public concern [with tacrolimus] is that the generic drugs are inferior to the brand-name drugs,” said Dr. Rita Alloway, UC professor of medicine and director of transplant clinical research who will be leading the study. “[The study will] look at all the approved generics and based on healthy patient trials and how quickly it dissolves. We then compare them to the brand name under the assumption that if the highest and lowest generic compare to the brand name then all generics will.”
Alloway will collaborate with Uwe Christians, a professor of anesthesiology at the University of Colorado, and Sander Vinks, a UC professor of pediatrics and director of the Division of Clinical Pharmacology at the Cincinnati Children’s Hospital Medical Center.
UC will collaborate with the University of Colorado and bring together many departments of UC’s medical campus.
“This very nicely demonstrates that if you combine forces from different sides and groups of the medical campus you can be very successful in getting a grant and I would likely say, some good data,” Vinks said.
The study will help UC stay at the forefront of transplant research.
“At the University of Cincinnati we’ve always been highly recognized as a leader in transplant research,” Alloway said. “Success is the best thing, and I think this is a hot topic within transplantation.”
Alloway and partners will travel to Washington, DC Monday to present the grant at a meeting to the FDA, the American Society of Transplantation and American Society of Transplant Surgeons.