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Pharmacy Choice - Pharmaceutical News - Aeterna Zentaris Announces EMA Pediatric Committee Agreement on the Pediatric Investigation Plan for Macrilen? - November 21, 2017

Pharmacy News Article

 3/20/17 - Aeterna Zentaris Announces EMA Pediatric Committee Agreement on the Pediatric Investigation Plan for Macrilen?

By a News Reporter-Staff News Editor at Pharma Business Week Aeterna Zentaris Inc. (NASDAQ: AEZS)(TSX: AEZS) (the "Company") announced that the Pediatric Committee ("PDCO") of the European Medicines Agency ("EMA") agreed to the Company's Pediatric Investigation Plan ("PIP") for Macrilen? and agreed that the Company may defer conducting the PIP until after it files a Marketing Authorization Application ("MAA") seeking marketing authorization for the use of Macrilen? for the evaluation of adult growth hormone deficiency (see also Pharmaceutical Companies).

As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. An accepted PIP is a prerequisite for filing an MAA for any new medicinal product in Europe. However, the Company will be able to file an MAA substantially earlier than if it was required to complete the PIP before filing, because the PDCO permitted the Company to defer conducting the studies defined in the PIP.

The Company's PIP provides for a dose-escalation safety and PK/PD study followed by a diagnostic efficacy and safety study. The goal of the first study is to establish a dose that can safely be administered to pediatric patients and that causes a clear rise in growth hormone concentration in subjects ultimately diagnosed as not having growth hormone deficiency ("GHD"). The recommended dose derived from this study will be evaluated in the second study for diagnostic efficacy and safety. Both studies will be conducted in patients at least three years old who are undergoing the study sites' regular diagnostic evaluation for the presence of GHD.

Keywords for this news article include: Pharmaceutical Companies, Marketing, Pediatrics, Advertising, Endocrinology, Peptide Hormones, Aeterna Zentaris Inc., Growth Hormone Deficiency, Anterior Pituitary Hormones.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2017, NewsRx LLC

(c) 2017 NewsRx LLC

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