FDA approves Aeterna's Macrilen

FDA approved a resubmitted NDA for Macrilen macimorelin acetate (Macrimorelin-GHST, AEZS-130) from Aeterna Zentaris Inc. (TSX:AEZS; NASDAQ:AEZS) for use in diagnosing adult growth hormone deficiency (AGHD). Aeterna plans to launch the oral ghrelin-mimetic growth hormone secretagogue in the U.S. in 1Q18.

Aeterna said Macrilen stimulates secretion of growth hormone into the circulatory system so that hormone levels can be measured in four blood samples over 90 minutes, making it more convenient than the current gold standard IV insulin tolerance test (ITT), which requires blood draws over several hours. ITT also may be contraindicated in some patients with heart disease or seizure disorders as it requires patient to experience hypoglycemia...