The European Medicines Agency granted marketing approval to Aeterna Zentaris Inc.'s macimorelin for the diagnosis of adult growth hormone deficiency.
Adult growth hormone deficiency, or AGHD, occurs when the body's anterior pituitary gland does not produce enough growth hormone. This stimulates the release of another hormone called insulin-like growth factor 1, which is mainly produced by the liver. Together, these hormones produce growth in childhood and adult life.
AGHD may occur in adults with a history of childhood-onset growth hormone deficiency or during adulthood as an acquired condition. About 35,000 adults could be afflicted with growth hormone deficiency, said Aeterna in its Jan. 16 press release.
The Summerville, S.C.-based biopharmaceutical company said trials showed that macimorelin, which stimulates the secretion of growth hormone from the pituitary gland into the circulatory system, was safer and simpler to administer than the current methods of testing for insulin-induced hypoglycemia, or low blood sugar levels. The medicine was also well-tolerated by patients and reliable in diagnosing the condition.
In November 2018, the Committee for Medicinal Products for Human Use recommended granting a marketing authorization to macimorelin, which is marketed in the U.S. as Macrilen, for diagnosing AGHD.
Strongbridge Biopharma PLC sold the U.S. and Canada rights to Macrilen to Novo Nordisk A/S, which it had acquired from Aeterna, in December 2018.