AGLE - Aeglea's ACN00177 nabs Orphan Drug tag ion the U.S. and Europe for a metabolic disorder
The FDA has designated Orphan Drug status to Aeglea BioTherapeutics' ([[AGLE]] -1.8%) to ACN00177 for the treatment of Homocystinuria, a metabolic disorder characterized by elevated plasma homocysteine which leads to a wide range of life-altering complications and reduced life expectancy.The company also announced that the European Medicines Agency Committee has issued a positive opinion recommending Orphan Drug tag for the investigational producti for the same indication.ACN00177 is a novel engineered human enzyme therapy designed to lower the total level of homocysteine in the plasma.Homocysteine accumulation plays a key role in multiple progressive and serious disease-related complications, including thromboembolic vascular events, skeletal abnormalities including severe osteoporosis, developmental delay, intellectual disability, lens dislocation and severe near-sightedness.
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Aeglea's ACN00177 nabs Orphan Drug tag ion the U.S. and Europe for a metabolic disorder