Repros Therapeutics Inc. (NASDAQ:RPRX) today announced that it has received confirmation of acceptance of its September 12, 2016 filing for enclomiphene in the treatment of secondary hypogonadism in Europe.
- Analogous to acceptance of an NDA by U.S. Food and Drug Administration
- Responses expected by end of January 2017
The MAA was submitted to the European Medicines Agency (EMA) by Renable Pharma Limited, the UK subsidiary of Repros.
As has been described in previous communications, the typical time from submission to authorization of a medicinal product through the EMA’s centralized procedure is 13-16 months and culminates in one authorization being obtained which is valid in all European Union and European Economic Area countries, i.e. 31 in total. The centralized procedure allows for a pan-EU review of the data, led by the Rapporteur’s and Co-Rapporteur’s assessment teams, and is governed by set timelines; therefore the review time is well defined. In this context, the Company expects to receive all questions relating to the application by the end of January 2017.
Dr. Michael Wyllie, Independent Director of Repros, commented: “The acceptance of the dossier by the EMA represents a key milestone toward the commercialization of enclomiphene and signals the acceptability and adequacy of the data for formal review. At a defined time point, ‘day 120’, toward the end of January, we expect to get an initial reaction from the examiners.”