CHARLESTON, SC, USA I November 19, 2018 I Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS), announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a marketing authorization for macimorelin, an orally available ghrelin agonist, for diagnosis of adult growth hormone deficiency (AGHD). The recommendation will now be reviewed by the European Commission.
“We are pleased with the CHMP’s positive opinion of macimorelin for AGHD,” said Michael V. Ward, Chief Executive Officer of Aeterna Zentaris.
Macimorelin is already approved by the Food and Drug Administration (FDA) in the United States for diagnosing AGHD and is commercially marketed as Macrilen™.
About AGHD
AGHD may occur in an adult subject who has a history of childhood onset growth hormone deficiency (GHD) or may occur during adulthood as an acquired condition. Considering a population of 510 million for the European Community, research based on incidence prevalence suggests that at least 35,000 adults could be afflicted with GHD.
About Macimorelin
Macimorelin stimulates the secretion of growth hormone from the pituitary gland into the circulatory system.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a biopharmaceutical company focused on developing and commercializing, principally through out-licensing arrangements, Macrilen™ (macimorelin), an oral ghrelin receptor agonist, to be administered in the diagnosis of patients with adult growth hormone deficiency. On November 27, 2017 Aeterna Zentaris announced that the Marketing Authorization Application (MAA) for the use of Macrilen™ (macimorelin) for the evaluation of AGHD was accepted by the European Medicines Agency (EMA) for regulatory review. Aeterna Zentaris has licensed Macrilen™ (macimorelin) to a subsidiary of Strongbridge Biopharma plc in the United States and Canada. For more information, visit www.zentaris.com.
SOURCE: Aeterna Zentaris
Post Views: 78
CHARLESTON, SC, USA I November 19, 2018 I Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS), announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a marketing authorization for macimorelin, an orally available ghrelin agonist, for diagnosis of adult growth hormone deficiency (AGHD). The recommendation will now be reviewed by the European Commission.
“We are pleased with the CHMP’s positive opinion of macimorelin for AGHD,” said Michael V. Ward, Chief Executive Officer of Aeterna Zentaris.
Macimorelin is already approved by the Food and Drug Administration (FDA) in the United States for diagnosing AGHD and is commercially marketed as Macrilen™.
About AGHD
AGHD may occur in an adult subject who has a history of childhood onset growth hormone deficiency (GHD) or may occur during adulthood as an acquired condition. Considering a population of 510 million for the European Community, research based on incidence prevalence suggests that at least 35,000 adults could be afflicted with GHD.
About Macimorelin
Macimorelin stimulates the secretion of growth hormone from the pituitary gland into the circulatory system.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a biopharmaceutical company focused on developing and commercializing, principally through out-licensing arrangements, Macrilen™ (macimorelin), an oral ghrelin receptor agonist, to be administered in the diagnosis of patients with adult growth hormone deficiency. On November 27, 2017 Aeterna Zentaris announced that the Marketing Authorization Application (MAA) for the use of Macrilen™ (macimorelin) for the evaluation of AGHD was accepted by the European Medicines Agency (EMA) for regulatory review. Aeterna Zentaris has licensed Macrilen™ (macimorelin) to a subsidiary of Strongbridge Biopharma plc in the United States and Canada. For more information, visit www.zentaris.com.
SOURCE: Aeterna Zentaris
Post Views: 78
