Posted by Michael Wonder on 28 Nov 2017
Aeterna Zentaris’ marketing authorization application for macrilen (macimorelin) for evaluation of adult growth hormone deficiency accepted by European Medicines Agency
27 November 2017 - Aeterna Zentaris announced that the Marketing Authorization Application for the use of Macrilen (macimorelin) for the evaluation of adult growth hormone deficiency (“AGHD”) has been accepted by the European Medicines Agency (“EMA”) for regulatory review.
On March 7, 2017, the Pediatric Committee of the EMA agreed to the company’s Pediatric Investigation Plan (“PIP”) for Macrilen™, a prerequisite for filing an MAA for any new medicinal product in Europe. The EMA also agreed that the company may defer conducting the PIP until after it filed a MAA for the use of Macrilen™ in AGHD. The start of the EMA review procedure for the MAA has now been confirmed by EMA as November 23, 2017.
