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news.Repros Therapeutics has formally activated the process for obtaining marketing authorization for enclomiphene in the treatment of secondary hypogonadism by the European Medicines Agency (EMA).
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Repros is seeking the enclomiphene marketing authorization for Europe through a central filing which is valid in all European Union and European Economic Area countries, i.e. 31 countries 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. Based on these timelines, the Company believes authorization to market enclomiphene in the EU can be obtained by the fourth quarter of 2017.
Importantly, EU approval would open potential marketing opportunities for enclomiphene to numerous non-US territories.
The EMA already recognizes secondary hypogonadism as a discrete disorder that requires medical intervention. This medical need is confirmed by Professor Fred Wu, Professor of Medicine and Endocrinology, University of Manchester and Principal Investigator in the European Male Aging Study who stated: "One of the most disabling but less recognized problems in obese men is low testosterone (secondary hypogonadism). With the increasing fattening of our society, there is a great need for effective medical treatment of secondary hypogonadism. Drugs, such as enclomiphene, that raise testosterone production in obese men, could be invaluable as part of the management of diabetic and obese patients."
Dr. John Dean, St. Peter’s Andrology Centre and past President of the International Society for Sexual Medicine, commented: "The majority of men with secondary hypogonadism, the most prevalent form of hypogonadism, are poorly served. In addition, for many men receiving existing T replacement there can be a counterproductive reduction in fertility.
"For these reasons the approval of enclomiphene has the potential to represent a substantial step forward in the management of this area of high, and increasing, medical need. Fortunately, the EMA appears to recognize secondary hypogonadism as a disorder requiring medical intervention."