Protara Therapeutics, Inc. announced on October 21, 2024, that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its investigational Intravenous (IV) Choline Chloride. This therapy is being developed as a phospholipid substrate replacement for adult and adolescent patients on parenteral support (PS) who cannot receive oral or enteral nutrition.
The Fast Track designation highlights the urgent need for such a therapy, as approximately 40,000 patients in the U.S. are on long-term parenteral support. Data indicates that about 80% of these patients experience choline deficiency, which can lead to severe hepatic injury, neuropsychological impairment, muscle damage, and thrombotic abnormalities.
There are currently no FDA-approved IV choline products available globally for PS patients. The Fast Track program facilitates development and expedites review, potentially allowing for accelerated approval and priority review, and enabling rolling submission of a New Drug Application. Protara plans to initiate its registrational THRIVE-3 clinical trial in the first quarter of 2025.
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