Diagnosis of adult growth hormone deficiency (AGHD).
Ghrelin agonist that stimulates the secretion of growth hormone from the pituitary gland into the circulatory system.
0.5 mg/kg PO as a single dose after fasting for at least 8 hours.
Approval was based on comparative test results between macimorelin and insulin tolerance test (ITT) results in adult patients with different pretest probability of growth hormone deficiency and healthy control subjects. Agreement between ITT and macimorelin was 89% for a positive diagnosis and 100% for a negative diagnosis of high likelihood of AGHD.
Macrilen (macimorelin) prescribing information. Aeterna Zentaris. Frankfurt am Main, Germany. December, 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205598s000lbl.pdf
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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.