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Protara Therapeutics Receives Fast Track Designation from U.S. FDA for Intravenous Choline Chloride for the Treatment of Intestinal Failure Associated Liver Disease
NEW YORK, May 26, 2020 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical stage company developing treatments for rare and specialty
About this update from Protara Therapeutics, Inc.
[{"type":"text","content":"NEW YORK, May 26, 2020 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical stage company developing treatments for rare and specialty diseases with significant unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Intravenous (IV) Choline Chloride for the treatment of intestinal failure-associated liver disease (IFALD). IV Choline Chloride is the Company’s Phase 3-ready investigational phospholipid substrate replacement therapy for patients receiving parenteral nutrition (PN) who have IFALD.\n “Receiving Fast Track designation from the FDA further supports the potential for IV Choline Chloride to serve as the much-needed first approved therapy for IFALD patients,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “We look forward to collaborating with FDA and utilizing the benefits associated with Fast Track designation to make this important therapy available for patients with IFALD.” Data from the randomized, controlled, Phase 2 trial in IFALD patients dependent on PN demonstrated that treatment with IV Choline Chloride resulted in normalization of plasma-free choline concentrations, reversal of hepatic steatosis, and a clinically meaningful and statistically significant improvement in cholestasis. Protara held an end of Phase 2 meeting with the FDA in late 2018 and received the FDA’s support to advance IV Choline Chloride into a registration-enabling study for the treatment of IFALD. About FDA Fast Track Designation The FDA’s Fast Track program facilitates the development and expedites the review of drugs that treat serious conditions and have the potential to address an unmet medical need. Programs with Fast Track designation may benefit from early and frequent interactions with the FDA over the course of drug development. In addition, the Fast Track designation program allows for the eligibility for accelerated approval and priority review if relevant criteria are met, and enables a company to submit individual sections of a New Drug Application (NDA) for review on a rolling-submission basis. About Intravenous (IV) Choline Chloride for IFALD Intravenous (IV) Choline Chloride is a Phase 3-ready investigational phospholipid substrate replacement therapy initially in development for patients receiving parenteral nutrition ...