Aeterna Zentaris Requests Fast Track Designation from the FDA for AEZS-130 as Diagnostic Test for Adult Growth Hormone Deficiency
Aeterna Zentaris Inc recently announced that it has filed a request with the United States Food and Drug Administration (FDA) for Fast Track designation for its oral ghrelin agonist, AEZS-130, as a diagnostic test for adult growth hormone deficiency (AGHD).
Aeterna Zentaris Inc recently announced that it has filed a request with the United States Food and Drug Administration (FDA) for Fast Track designation for its oral ghrelin agonist, AEZS-130, as a diagnostic test for adult growth hormone deficiency (AGHD). The request is part of the company's New Drug Application (NDA) strategy for AEZS-130 to advance the product towards regulatory approval as efficiently as possible.
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.
Juergen Engel, PhD, President and CEO of Aeterna Zentaris stated, "After a lengthy series of informative discussions with the FDA, we now have the valuable guidance needed to move ahead as quickly as possible with our NDA filing plans. In conjunction with that, obtaining Fast Track designation would give us the opportunity to submit our NDA on a rolling basis. This means we could submit certain modules of our NDA progressively, with the expectation that review of those portions of the NDA would be complete or well underway before we complete the NDA submission. Should we obtain agreement on our Fast Track designation and rolling submission strategy, we would expect to begin filing modules before year-end and complete the NDA submission in the first quarter of 2013. Furthermore, we believe our request for Fast Track designation is warranted since there is currently no approved diagnostic test for AGHD in North America, and AEZS-130 could provide a safe and effective test which would be more convenient because it is administered orally."
About Fast Track Designation
The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
The rolling submission is an FDA provision available to drug candidates that have received Fast Track designation, and allows for completed sections of an NDA to be submitted on an ongoing basis.
AGHD affects 35,000 adult Americans, with 6,000 new adult patients diagnosed each year. Growth hormone not only plays an important role in growth from childhood to adulthood, but helps promote good health throughout life. AGHD is usually characterized by low energy levels, decreased strength and exercise tolerance, increased weight or difficulty losing weight, emotional changes, anxiety and impaired sleep.
AEZS-130, a ghrelin agonist, is a novel orally-active small molecule that stimulates the secretion of growth hormone. The Company 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. AEZS-130 is also in a Phase 2A trial as a treatment for cancer induced cachexia. Aeterna Zentaris owns the worldwide rights to AEZS-130.
About Aeterna Zentaris
Aeterna Zentaris is an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs. The Company's pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. For more information please visit www.aezsinc.com.
SOURCE: Aeterna Zentaris