Québec City, Canada, July 24, 2012 – Aeterna Zentaris Inc (NASDAQ: AEZS) (TSX: AEZ) (the “Company”) today announced 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.”
Source: Aeterna Zentaris
Last Updated: 7/25/12; 11:05am EST