FDA Approves Drug – Treats Rare Metabolic Disorder
09/10/2015 // JusticeNewsFlash // Justice News Flash // (press release)
Washington – The U.S. Food and Drug Administration has approved a new treatment for patients with hereditary orotic aciduria. The FDA recently issued a release stating the drug Xuriden (uridine triacetate) is the first to be approved by the agency for treating the rare metabolic disorder.
Hereditary orotic aciduria is a disease that is inherited from a recessive gene, and linked to an enzyme deficiency that leaves the body incapable of synthesizing uridine. Symptoms of the condition include abnormalities of the blood, obstruction of the urinary tract, developmental delays, and other issues.
The FDA is quoted as stating in its release about the drug approval “Today’s approval and rare pediatric disease priority review voucher underscore the FDA’s commitment to making treatments available to patients with rare diseases.”
Amy G. Egan, M.D., M.P.H., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER), further stated “Prior to Xuriden’s approval, patients with this rare disorder had no approved treatment options.”
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Source: FDA Press Release http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm457867.htm