Human medicines European public assessment report (EPAR): GHRYVELIN (previously Macimorelin Aeterna Zentaris), macimorelin, Diagnostic Techniques, Endocrine, Date of authorisation: 11/01/2019, Revision: 3, Status: Authorised
GHRYVELIN was compared with another test commonly used to diagnose growth hormone deficiency, called insulin tolerance test (ITT), in one main study.
The study involved 166 adults who had either a high, intermediate or low likelihood of having growth hormone deficiency, or who were confirmed not to have growth hormone deficiency. Among them, 140 were tested with both GHRYVELIN and ITT.
Overall, 94% of people who tested negative for growth hormone deficiency with ITT also tested negative with GHRYVELIN; 74% of people who tested positive with ITT also tested positive with GHRYVELIN. This means that, although GHRYVELIN might not diagnose all cases of disease, it can help to confirm presence of the disease.
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