AGHDAdult Growth Hormone Deficiency
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The study population consisted of 115 patients who were suspected of having AGHD as a result of the presence of one or more symptoms or risk factors.
The company believes that if Macrilen is approved by the FDA, approximately 40,000 confirmatory tests for AGHD will be conducted each year in the US alone.
When AGHD is treated with GH, there are usually increases in GH, IGF-1 and IGF binding protein 3 (IGFBP-3), which all have a role in clinical results.
The company added the United States Food and Drug Administration's (FDA) Fast Track designation had not been granted for its for AEZS-130 as a diagnostic test for adult growth hormone deficiency (AGHD).
6 October 2010 - Canadian Aeterna Zentaris Inc (TSE: AEZ) said yesterday that an interim review of a Phase III study of AEZS-130 (macimorelin, Solorel) demonstrates that the compound may provide a well-tolerated and safe oral diagnostic test for Adult Growth Hormone Deficiency (AGHD).