Repros Therapeutics files MAA at EMA for enclomiphene to treat hypogonadism.
Repros Therapeutics 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 to the European Medicines Agency (EMA) by Renable Pharma Limited, the U.K. subsidiary of Repros.
Comment:The FDA in a Complete Response Letter, issued in December 2015, has indicated that, based on recent scientific developments, the design of enclomiphene Phase III studies is no longer adequate to demonstrate clinical benefit and recommended that Repros conduct an additional Phase III study or studies to support approval in the target population. The FDA also noted concerns regarding study entry criteria, titration and bioanalytical method validation in the Phase III program.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.