FDA grants Fast Track designation to 64-Cu-Dotatate

por John R. Fischer, Senior Reporter | January 11, 2019
Molecular Imaging
The FDA has awarded Fast Track
designation for use of 64-Cu-Dotatate
The FDA has awarded Fast Track designation to 64-Cu-Dotatate, an investigational diagnostic radiopharmaceutical currently in the process of being developed and commercialized by RadioMedix and Curium.

A PET diagnostic agent for identifying somatostatin receptor expressing neuroendocrine tumors, 64-Cu-Dotatate can be produced at a central location in quantities, making its clearance significant for addressing supply limitations of nuclear generator-based PET isotopes, particularly the lack of somatostatin analogue PET agents available in many parts of the U.S.

“The FDA Fast Track designation of 64Cu-Dotatate highlights the public health need by enhancing the availability of diagnostic radiopharmaceuticals for patients with neuroendocrine tumors,” Ebrahim Delpassand, M.D., CEO of RadioMedix, said in a statement. “64-Cu-Dotatate is anticipated to be the first neuroendocrine PET diagnostic available to ALL medical centers with PET capability across the country.”

RadioMedix and Curium teamed up on development and commercialization of the agent beginning this past summer, adding Curium’s manufacturing, distribution and commercial experience to build on the initial development work carried out by RadioMedix.

The central manufacturing quality of the agent is due to its 12-hour half-life, which allows Curium to produce it at its state-of-the-art Maryland Heights, Missouri facility and then deliver it to hospitals and imaging centers nationwide through its existing isotope distribution network.

“Our ability to manufacture 64-Cu-Dotatate at a central location and distribute quantities to meet the needs of hospitals and imaging centers demonstrates our continued commitment to help patients with neuroendocrine tumors,” said Dan Brague, Curium CEO for North America. “We look forward to partnering with RadioMedix to commercialize this important diagnostic agent pending FDA approval.”

RadioMedix has completed the Phase III clinical trial of the agent and expects to file a New Drug Application with the FDA at some point this year.

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