Repros Provides Update on EU Submission of Enclomiphene for the Treatment of Secondary Hypogonadism and 3 Month Interim Results for Enclomiphene Study in Obese Secondary Hypogonadal Men
EU submission on track with anticipated registration decision expected Fall 2017
UK designated as rapporteur and France as co-rapporteur for the centralized review of the enclomiphene marketing application
3 month interim assessment of testosterone levels in obese men participating in Phase 2 diet and exercise study show statistically significant increases in testosterone in the active arms versus the placebo arm
THE WOODLANDS, Texas, June 01, 2016 -- Repros Therapeutics Inc.® (RPRX) today announced that it remains on track for submission of a European centralized marketing authorization application (MAA) for enclomiphene for the treatment of secondary hypogonadism. To that end, the European Medicines Agency (EMA) has assigned France and the UK as rapporteurs for the application review. The Company expects to submit the application in Fall 2016. As part of the review process, the Company is scheduled to meet with British and French medical reviewers in June 2016.
- Published: 02 June 2016
- Written by Editor