The European Medicines Agency accepted for review 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 oral administration of Macrilen for the assessment of growth hormone deficiency.
AGHD affects about 75,000 adults across the U.S., Canada and Europe. It is characterized by a reduction in bone mineral density, lean body mass, exercise capacity and overall quality of life as well as an increase of cardiovascular risks.
Macimorelin has been granted orphan drug designation by the U.S. Food and Drug Administration for diagnosis of AGHD.
