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US FDA approves Dimension Therapeutics' application for urea cycle disorder drug
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The U.S. FDA accepted Dimension Therapeutics Inc.'s investigational new drug application for DTX301 to treat ornithine transcarbamylase deficiency, a genetic disorder that causes ammonia to accumulate in the blood.
Dimension expects to start a phase 1/2 clinical trial to evaluate the urea cycle disorder drug in patients with the deficiency by the end of 2016.