Aeterna Zentaris Inc. (AEZS, AEZ.TO) said it has filed a request with the United States Food and Drug Administration, or FDA, for Fast Track designation for its oral ghrelin agonist, AEZS-130, as a diagnostic test for adult growth hormone deficiency.
The request is part of the company's New Drug Application strategy for AEZS-130 to advance the product towards regulatory approval as efficiently as possible.
Juergen Engel, president and CEO of Aeterna Zentaris, said, "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."
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