FDA Approves Macrilen for Adult Growth Hormone Deficiency Diagnosis
The Food and Drug Administration (FDA) has approved Macrilen (macimorelin; Aeterna Zentaris) for use in the diagnosis of patients with adult growth hormone deficiency (AGHD).
Prior to the approval of Macrilen, the insulin tolerance test was considered the 'gold standard' to evaluate for AGHD. Macrilen, an orally available ghrelin agonist, stimulates the secretion of growth hormone from the pituitary gland into the circulatory system. The hormone levels are then measured in 4 blood samples over 90 minutes after oral administration to assess for growth hormone deficiency.
“The availability of Macrilen will greatly relieve the burden of endocrinologists in reliably and accurately diagnosing AGHD.” said Kevin Yuen, MD, clinical investigator and neuroendocrinologist, Barrow Neurological Institute, and medical director of the Barrow Neuroendocrinology Clinic, Phoenix, Arizona.
The approval of Macrilen was based on a confirmatory Phase 3 study involving 157 subjects, 115 of which were suspected of having AGHD. The use of Macrilen was compared with insulin tolerance test in an open-label, randomized, 2-way crossover study.
Macrilen is expected to be available in the U.S. during the first quarter of 2018.
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