Dr. Klaus Paulini reports
AETERNA ZENTARIS ANNOUNCES EMA DECISION TO ACCEPT A MODIFICATION TO AN AGREED PEDIATRIC INVESTIGATION PLAN FOR MACIMORELIN
Aeterna Zentaris Inc. has received a decision from the European Medicines Agency (EMA) to accept a modification request by Aeterna Zentaris of the company's pediatric investigation plan (PIP) for macimorelin as originally approved in March, 2017, which covered the conduct of two pediatric studies and defined relevant key elements in the outline of these studies.
The company recently announced the positive results and successful completion of the first of these studies, study P01. The goal of study P01 was to establish a dose that could both be safely administered to pediatric patients and cause a clear rise in growth hormone concentration in subjects ultimately diagnosed as not having GHD.
The second pediatric study, study P02, is designed to investigate the diagnostic efficacy and safety of macimorelin acetate in pediatric patients from two years of age to 18 years of age with suspected growth hormone deficiency.
"This EMA decision is an important milestone for us, as it supports the development of one globally harmonized study protocol for test validation -- study P02 -- which will be accepted both in Europe and the United States of America," said
Dr. Klaus Paulini, chief executive officer of Aeterna Zentaris.
"A request for modification of the PIP related to some of the key elements of study P02 became necessary for Aeterna Zentaris, as we wanted to ensure that the study protocol will comply with expectations and requirements from both EMA, as well as United States Food and Drug Administration. This represents a very exciting advancement for our pediatric development program," commented,
Dr. Nicola Ammer, chief medical officer of Aeterna Zentaris.
About Aeterna Zentaris Inc.
Aeterna Zentaris 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-approved and European Commission-approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD).
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