Aeterna Zentari expects to file AEZS-130 NDA with FDA for adult growth hormone deficiency

Sep 27 2012

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that it continues to expect to file a New Drug Application (NDA) early next year, for its oral ghrelin agonist, AEZS-130, as a diagnostic test for adult growth hormone deficiency (AGHD), after receiving notification from the United States Food and Drug Administration (FDA) that Fast Track designation had not been granted.

Juergen Engel, PhD, President and CEO of Aeterna Zentaris stated, "Although the FDA's decision will not allow us to submit our New Drug Application on a rolling basis, it should not affect the timing of our filing of the NDA for AEZS-130, which is expected early next year, nor should it affect the potential of obtaining priority review. We are actively pursuing our strategy to advance AEZS-130 towards regulatory approval for AGHD, as it could become the first orally administered test in this indication."

SOURCE AETERNA ZENTARIS INC.