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 review of new drugs that are intended for treating serious or life-threatening conditions and also demonstrate the potential to address unmet medical needs. Ordinarily, Fast Track designated drugs qualify for priority review, which expedites the FDA review process.
Aeterna Zentaris has been involved in a lengthy series of informative discussions with the FDA and now has the guidance needed to move ahead as speedily as possible with its NDA filing plans. Obtaining Fast Track designation would allow the company to submit its NDA on a rolling basis, which means Aeterna Zentaris could submit certain modules of its NDA progressively, with the expectation that the review of those portions would be completed or well underway before the NDA submission is complete. If the company obtains agreement on its Fast Track designation and rolling submission strategy, it would expect to begin filing modules before the end of 2012 and to complete the NDA submission in the first quarter of 2013. Aeterna Zentaris believes its Fast Track request is justified, as there is currently no approved diagnostic test for AGHD in North America. AEZS-130 could provide a test that is safe and effective and also convenient, because it is administered orally.
Affecting 35,000 adult Americans, AGHD is generally characterized by low energy levels, decreased strength and exercise tolerance, increased weight or difficult losing weight, emotional changes, anxiety, and sleep impairment. Every year, 6,000 new adult patients are diagnosed with AGHD.
AEZS-130 is a ghrelin agonist that is a novel orally active small molecule that stimulates the secretion of growth hormone. Aeterna Zentaris has completed a phase 3 trial for use of the product as an oral diagnostic test for AGHD. The product 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. Global rights to AEZS-130 are owned by Aeterna Zentaris.
Aeterna Zentaris, an oncology and endocrinology drug development company, is currently investigating treatments for a variety of unmet medical needs. The company’s pipeline includes compounds at all stages of development, from drug discovery through marketed products.
For more information, visit the company’s Web site at www.aezsinc.com
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