The U.S. Food and Drug Administration granted marketing approval to Aeterna Zentaris Inc.'s Macrilen for the evaluation of adult growth hormone deficiency, or AGHD.
Macrilen, also known as macimorelin, stimulates the secretion of growth hormone from the pituitary gland. Stimulated growth hormone levels are measured in blood samples after taking the drug for the assessment of growth hormone deficiency.
The historical gold standard for evaluation of AGHD was the insulin tolerance test, an intravenous test requiring many blood draws over several hours.
Aeterna Zentaris plans to make Macrilen commercially available in the U.S. during the first quarter of 2018.
