2020-12-01 07:31:48 AGLE Aeglea BioTherapeutics
12/01/20 12/0107:31 12/01/2007:31 | Aeglea receives FDA Rare Pediatric Disease Designation for ACN00177Aeglea BioTherapeutics announced the FDA has granted Rare Pediatric Disease Designation to ACN00177 for the treatment of Homocystinuria, a serious metabolic disorder characterized by elevated plasma homocysteine which leads to a wide range of life-altering complications and reduced life expectancy. ACN00177 is a novel engineered human enzyme therapy designed to lower the total level of homocysteine in the plasma. Aeglea initiated a Phase 1/2 clinical trial earlier this year to investigate ACN00177 for the treatment of Homocystinuria. The FDA grants rare pediatric disease designation for diseases with serious or life-threatening manifestations that primarily affect fewer than 200,000 people in the United States and who are less than 18 years old. |
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