FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Macrilen (macimorelin)

Indication:

Diagnosis of adult growth hormone deficiency (AGHD).

Mechanism:

Ghrelin agonist that stimulates the secretion of growth hormone from the pituitary gland into the circulatory system.

Dosage:

0.5 mg/kg PO as a single dose after fasting for at least 8 hours.

Approval:

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.

Reference:

Macrilen (macimorelin) prescribing information. Aeterna Zentaris. Frankfurt am Main, Germany. December, 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205598s000lbl.pdf

Medscape © 2018 WebMD, LLC

Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.

Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.