Thursday, January 22, 2015

FDA Issues Complete Response Letter for Macrilen (macimorelin) NDA in Adult Growth Hormone Deficiency


Macimorelin is a drug being developed by Ă†terna Zentaris for use in the diagnosis of adult growth hormone deficiency. As of January 2014, it is in Phase III clinical trials. 
Macimorelin is a mimic of ghrelin, a growth hormone secretagogue. It binds to the growth hormone secretagogue receptor(GHSR) causing release of growth hormone from the pituitary gland.

Now, Aeterna Zentaris Inc. today announced that the Company has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) for its New Drug Application (“NDA”) for Macrilen (macimorelin), a novel orally-active ghrelin agonist, for use in evaluating adult growth hormone deficiency (“AGHD”). Based on its review, the FDA has determined that the NDA cannot be approved in its present form.

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