Barrett J. Brunsman Staff reporter- Cincinnati Business Courier
A federal grant of $2.3 million will enable a researcher at the University of Cincinnati to continue to study a drug designed to help high-risk organ transplant patients.
Rita Alloway, a UC research professor of medicine and director of transplant clinical research within the UC Department of Internal Medicine, said the three-year grant from the U.S. Food and Drug Administration will help pay for two clinical trials.
She plans to study the effects of the drug tacrolimus, which lowers the risk of organ rejection by suppressing a patient’s immune system.
A brand-name version called Prograf is a prescription drug used with other medicines to help prevent rejection in patients who have had a kidney, liver or heart transplant. Generic forms of tacrolimus, which were introduced in 2009, are dispensed to more than 70 percent of transplant patients, Alloway estimated.
“The largest concern for clinicians is the switchability between various generics,” Alloway said. “When patients receive their prescription, they could be getting medication from different manufacturers each month. Most immunosuppressant drugs require individualized dosing and careful management to ensure the proper blood concentrations are maintained.”
Last year, Alloway received a $2.7 million grant from the FDA to study whether the two most disparate generic versions of tacrolimus are bioequivalent to the branded version of the drug in stable transplant patients.
“The results of these studies should address public concerns regarding the use of generic tacrolimus,” she said.