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

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

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

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....