Repros Therapeutics (RPRX) Submits MAA for Enclomiphene to EMA as Secondary Hypogonadism Treatment
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Repros Therapeutics Inc. (Nasdaq: RPRX) announced that, as anticipated, it has activated the process for obtaining a marketing authorization (MAA) for enclomiphene in the treatment of secondary hypogonadism in Europe.
The MAA has been submitted today to the European Medicines Agency (EMA) by Renable Pharma Limited, the U.K. subsidiary of Repros.
The typical time from submission to authorization of a medicinal product through the 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 that establish a well-defined review time.
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 (EMAS), 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. Michael Wyllie, Independent Director of Repros, commented: “The submission for approval by the EMA represents a key milestone toward the commercialization of enclomiphene. Not only is the MAA timeline definable, but obtaining authorization would potentially allow access to a considerable patient population, with the EU adult male population being 165% of that in the US. The data from Professor Wu’s EMAS study indicates that the prevalence of secondary hypogonadism is significantly greater than the occurrence of primary hypogonadism.”
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