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     151  0 Kommentare Aeterna Zentaris Announced Presentation of Positive Results from First Pediatric Study of Macimorelin at the 22nd European Congress of Endocrinology - Seite 2

    Abstracts for the e-ECE 2020 conference have been published in Endocrine Abstracts. Endocrine Abstracts is an entirely online, open-access and fully citable collection of all the abstracts from e-ECE 2020.

    For more information about Study P01, please visit EU Clinical Trials Register and reference EudraCT #2018-001988-23.

    About e-ECE 2020

    The European Congress of Endocrinology is the European Society of Endocrinology’s premier event, attracting over 3,500 international delegates each year across the spectrum of endocrinology. The event is a showcase of the best of science and clinical practice across the fields of endocrinology and metabolism, and aims to deliver to all audiences interested in the field, whether you are an experienced consultant, a scientist or a nurse, and whether you are well advanced in your career or just starting out. e-ECE 2020 is this year’s fully digital Congress bringing you the latest innovations in endocrine research and patient care. For more information, please visit the event website.

    About Macimorelin

    Macimorelin, a ghrelin agonist, is an orally-active small molecule that stimulates the secretion of growth hormone from the pituitary gland. Stimulated growth hormone levels are measured in blood samples after oral administration of macimorelin for the assessment of GHD.

    In December 2017, the United States Food and Drug Administration (“FDA”) granted Aeterna Zentaris marketing approval for Macrilen to be used in the diagnosis of patients with adult growth hormone deficiency (AGHD). Macimorelin acetate has been granted Orphan Drug designation by the FDA for diagnosis of GHD. In January 2019, the European Commission granted marketing authorization for macimorelin to Aeterna Zentaris for diagnosis of growth hormone deficiency in adults. In March 2017, the Pediatric Committee of the EMA agreed to the Company’s PIP for macimorelin, a prerequisite for filing a marketing authorization application for any new medicinal product in Europe.

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    About Aeterna Zentaris Inc.

    Aeterna Zentaris Inc. is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company’s lead product, Macrilen (macimorelin), is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Macrilen is currently marketed in the United States through a license agreement with Novo Nordisk and Aeterna Zentaris receives double-digit royalties on sales. Aeterna Zentaris owns all rights to macimorelin outside of the U.S. and Canada.

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    Aeterna Zentaris Announced Presentation of Positive Results from First Pediatric Study of Macimorelin at the 22nd European Congress of Endocrinology - Seite 2 - PK and PD profiles of macimorelin for pediatric use were within the expected range and comparable to results observed in adults - - Data from this study support the choice of 1.0 mg/kg dose of macimorelin for validity testing in a Phase 3 …