Cu 64 dotatate injection: FDA Filing of drug in process

Houston and St Louis: RadioMedix Inc and its commercial partner, Curium, recently announced that the New Drug Application for copper Cu 64 dotatate injection was filed with the U.S. Food and Drug Administration (FDA).

The copper Cu 64 dotatate injection is a PET diagnostic agent intended for somatostatin receptor (SSTR) expressing neuroendocrine tumors (NETs).

The FDA previously granted Fast Track designation to copper Cu 64 dotatate injection. “If approved, we expect that the copper Cu 64 dotatate injection will be the first FDA approved Cu 64 labeled radiopharmaceutical for PET/CT imaging. Additionally, this drug will provide an exciting new imaging agent for NET physicians, patients and caregivers," said Chief Executive Officer (CEO) of RadioMedix, Ebrahim Delpassand.

“The copper Cu 64 dotatate injection will be the first neuroendocrine PET diagnostic agent available to all medical centers with PET capability across the country. This will alleviate the scheduling and supply challenges many geographies have experienced with other somatostatin analog PET agents. We are currently pursuing a Priority Review with the FDA to expedite commercial availability."

“If approved, the clinical utility of this new agent will allow Curium to enhance patient care in the US by bringing the accuracy of PET SSTR to all hospitals and imaging centers,” said Curium CEO, North America, Dan Brague.

“Our ability to manufacture copper Cu 64 dotatate injection at a central location and distribute quantities to meet the needs of hospitals and imaging centers demonstrates our continued focus on patients with neuroendocrine tumors.

We are excited to be bringing Cu 64, an exciting new isotope for PET imaging, to the market. We look forward to exploring additional applications that can help patients and physicians.”

RadioMedix, Inc is a clinical-stage biotechnology company, based in Houston, Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. The company is commercializing radiopharmaceuticals for PET imaging and therapeutic (alpha and beta-labeled) radiopharmaceuticals. RadioMedix has also established contract service facilities for its academic and industrial partners. These include full cGMP (current Good Manufacturing Practice) manufacturing and analytical suites for human clinical trials, commercial phase manufacturing of the radiopharmaceuticals, and small animal Molecular Imaging Center for the pre-clinical evaluation of new targets in vitro and in vivo.