Posted by Michael Wonder on 02 Jun 2022
Aeglea BioTherapeutics receives refusal to file letter from FDA for pegzilarginase for the treatment of arginase 1 deficiency
2 June 2022 - Aeglea BioTherapeutics today announced that it received a refusal to file letter from the U.S. FDA regarding the company's biologics license application for pegzilarginase for the treatment of arginase 1 deficiency.
In the refusal to file letter the FDA requested additional data to support effectiveness, such as evidence showing that plasma arginine and metabolite reduction predicts clinical benefit in patients with arginase 1 deficiency or clinical data demonstrating a treatment effect on clinically meaningful outcomes.
