Aeterna Zentaris announced that it has filed a request with the FDA for Fast Track designation for AEZS-130 for use as a diagnostic test for adult growth hormone deficiency (AGHD). The request is part of Aeterna Zentaris’ New Drug Application (NDA) strategy for AEZS-130.
The FDA’s Fast Track program is designed, among other things, to facilitate the development and expedite the review of new drugs that demonstrate the potential to address unmet medical needs. According to its guidance on Fast Track applications, the FDA responds within 60 days of receipt of such requests.
AEZS-130, a ghrelin agonist, is a novel orally-active small molecule that stimulates the secretion of growth hormone. Aeterna Zentaris has completed a Phase 3 trial for use as an oral diagnostic test for AGHD. AEZS-130 has been granted orphan drug designation by the FDA for use in this indication.
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