Schering AG's Climodien approved in EU

Germany's Schering AG has been granted approval throughout the EuropeanUnion for Climodien (dienogest and estradiol valerate), a new combination hormone replacement therapy which was approved in the Netherlands in December last year (Marketletter January 29). Schering noted that the drug will be launched in Germany in the fall, with introductions in a number of other EU countries following in subsequent months.

Dienogest is a novel progestin which exhibits highly selective binding to the progesterone receptor. It has high progestational and significant antiandrogenic activity, but only moderate antigonadotrophic activity. This profile allows Climodien to be taken without any monthly break in therapy, preventing a return to menstrual bleeding which can occur with other treatments like sequential or cyclical HRT. Women taking Climodien should see no bleeding after about six to eight months' treatment, according to Schering.