CHMP recommends approval of Macimorelin as diagnostic for growth hormone deficiency.- Aeterna Zentaris.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Macimorelin (macimorelin), from Aeterna Zentaris, a peptide mimetic with growth hormone secretagogue activity similar to ghrelin, intended for the diagnosis of growth hormone deficiency in adults. The medicinal will be available as 60 mg granules for oral solution. Macimorelin stimulates growth hormone release by activating growth hormone secretagogue receptors present in the pituitary and hypothalamus.
The benefit with Macimorelin Aeterna Zentaris is its ability to confirm diagnosis of growth hormone deficiency with high sensitivity and specificity in adult patients. The most common side effects are dysgeusia, dizziness, headache, fatigue, feeling hot, nausea and diarrhoea. The full indication is: "This medicinal product is for diagnostic use only. Macimorelin Aeterna Zentaris is indicated for the diagnosis of growth hormone deficiency (GHD) in adults."
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