Aeglea Gets RTF Letter Regarding BLA For Pegzilarginase - Quick Facts

(RTTNews) - Aeglea BioTherapeutics, Inc. (AGLE) has received a Refusal to File letter from the FDA regarding the company's Biologics License Application for pegzilarginase for the treatment of Arginase 1 Deficiency. The FDA requested additional data to support effectiveness. The FDA also requested additional information relating to Chemistry Manufacturing and Controls.

Aeglea said it intends to request a type A meeting with the FDA to clarify and respond to the items identified in the RTF letter.

"We believe the requests identified in the RTF letter related to CMC can be readily addressed and we intend to work collaboratively with the FDA to identify a viable path forward to demonstrate that lowering plasma arginine confers clinical benefit," said Anthony Quinn, CEO.