Aeterna Zentaris, Inc. (AEZS) Requests FDA Fast Track Designation for AEZS-130 as an AGHD Diagnostic Test
Oncology and endocrinology drug development company Aeterna Zentaris announced it has filed a request with the United States Food and Drug Administration for Fast Track designation for AEZS-130, the company’s oral ghrelin agonist, as a diagnostic test for adult growth hormone deficiency (AGHD). This request is part of Aeterna Zentaris’ New Drug Application (NDA) strategy for AEZS-130, to advance the product toward regulatory approval in the most efficient way possible. According to the FDA’s guidance for Fast Track applications, the FDA responds to such requests within 60 days of receipt. The Fast Track program facilitates the development and expedites the…