Telix Granted FDA Orphan Drug Designation for Glioma Imaging Agent

Melbourne (Australia) – 6th October 2020. Telix Pannounces FDA has granted Orphan Drug Designation (ODD) for O-(2-[¹⁸F]fluoroethyl)-L-tyrosine for PET imaging of glioma

Telix Pharmaceuticals Limited is pleased to announce that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for O-(2-[¹⁸F]fluoroethyl)-L-tyrosine (¹⁸F-FET), for the positron emission tomography (PET) imaging of glioma, a type of brain tumour.

The granting of an ODD for ¹⁸F-FET qualifies Telix for various drug development incentives which may include FDA-administered market exclusivity for seven years, waived FDA prescription drug user fees, and tax credits for R&D and clinical development costs.

Telix CEO Dr Christian Behrenbruch said,
“PET imaging of the brain is increasingly used to supplement conventional imaging with MRI, which for many years has been the primary clinical imaging modality in patients with glioma at all stages of disease. The granting of an Orphan Drug Designation by the FDA for ¹⁸F-FET provides Telix with the option to develop this valuable PET imaging agent commercially, to ensure it is available to patients with glioma across the disease spectrum. ¹⁸F-FET’s relevance as a patient selection and therapeutic monitoring tool for TLX101 is particularly beneficial to the Company”

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