Blue Earth Diagnostics has received two orphan drug designations for its F-18 fluciclovine radiopharmaceutical for diagnosing glioma.
The designations come from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the company said.
The investigational PET radiopharmaceutical is based on a synthetic amino acid and appears to be preferentially taken up in a number of cancer indications, including prostate cancer and brain tumors.
The orphan drug program is designed for pharmaceuticals for rare conditions, for which their developers are not expected to recoup the costs of development. The designation qualifies the drug sponsor for various incentives, including potential tax credits, the waiver of certain fees, and a period of marketing exclusivity.
