Theragnostics announces that NephroScan, its radiodiagnostic imaging drug used as an aid for the evaluation of renal parenchymal disorders in adult and pediatric patients, including term neonates, has received Marketing Approval by the US Food and Drug Administration (“FDA”).
NephroScan, a proprietary kit for the preparation of technetium Tc 99m succimer injection, is Theragnostics’ first FDA approved drug. It is manufactured by ROTOP Pharmaka GmbH in Germany. GE Healthcare, a global leader in molecular imaging, serves as the exclusive distributor of the product in the United States and the product is now available for ordering.
Greg Mullen, President and Chief Executive Officer of Theragnostics, said: “The FDA approval of NephroScan is a significant milestone for Theragnostics and for patients who are affected by kidney disease. NephroScan enables the detection and diagnosis of kidney disease, enabling physicians, patients, and their families to help make informed treatment decisions. The approval has been a remarkable team effort in collaboration with the regulatory development group at Facet Life Sciences and the specialists for radiopharmaceutical development and manufacturing at ROTOP Pharmaka GmbH.”
Dr. Ted Treves, Professor of Radiology at Harvard Medical School and former Chief Division of Nuclear Medicine at Boston Children’s Hospital said: “The value of Tc-99m DMSA is well established in the assessment of disorders affecting the kidneys in children and adults. The approval in the US means that Tc-99m DMSA imaging will be brought back as a useful tool for the evaluation of adult and pediatric patients affected by renal diseases. Efforts are underway for renewed education of referring physicians about its value and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) practice guidelines have recently been updated1.”
Important Safety Information: Radiation Risks: Technetium Tc 99m succimer injection contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to hydrate before and after administration and to void frequently after administration.
Advanced Renal Failure: Some patients with advanced renal failure may exhibit poor renal intake of technetium Tc 99m succimer injection. It has been reported that satisfactory images may be obtained in some of these patients by delaying imaging for up to 24 hours.
