Aeterna Zentaris Inc. plans to submit a new drug application with the U.S. FDA for approval of Macrilen for the evaluation of growth hormone deficiency in adults.
Previously, the phase 3 clinical trial of Macrilen failed to achieve its objective of validating a single oral dose of the drug, using the insulin tolerance test as a comparator.
Chief scientific officer Richard Sachse said in a statement that the FDA stated that the clinical studies Aeterna performed for Macrilen address prior deficiencies mentioned in a November 2014 complete response letter.
According to Sachse, the FDA indicated that conclusions regarding the performance of the drug are review issues subject to an examination of the complete data set and that the summary data the company submitted appear to support the propositions Aeterna advanced. He said the agency also specified the additional statistical analysis of existing data that would be required to further support Aeterna's conclusions.
President and CEO David Dodd said in a statement that although there is no assurance of approval of any new drug application, Aeterna believes it is closer to the commercialization of the drug in the U.S.