FDA accepts Aeterna's resubmitted NDA for GHD candidate Macrilen

FDA accepted for review a resubmitted NDA from Aeterna Zentaris Inc. (TSX:AEZS; NASDAQ:AEZS) for Macrilen macimorelin acetate (Macrimorelin-GHST, AEZS-130) to evaluate adult growth hormone deficiency (AGHD). Its PDUFA date is Dec. 30.

FDA issued a complete response letter in 2014, citing that the company’s pivotal trial did not meet the primary efficacy endpoint as agreed to in an SPA and mentioned issues related to the “lack of complete and verifiable source data for determining whether patients were accurately diagnosed with AGHD.” The agency requested a new, confirmatory study to demonstrate efficacy of the oral ghrelin-mimetic growth hormone secretagogue (see BioCentury, Nov. 24, 2014)...