Schering's Nebido gets Finnish approval for testosterone deficiency
Schering AG received approval in Finland, the first European country, for Nebido, a new type of depot preparation for the treatment of hypogonadism (testosterone deficiency) in men. Following the European Mutual Recognition Process, Schering expects approval for Nebido to follow in more European countries in the course of 2004. In addition, Schering plans to apply for approval in Latin American countries and Canada next year.
"Requiring only four injections per year, Nebido represents a major improvement for men suffering from testosterone deficiency. Previously, patients received on average 22 injections per year. Additionally the unique formulation of Nebido allows for a blood level of testosterone within the physiological range and is therefore more compatible with the patients needs," said Dr Philip Smits, head of gynecology & andrology at Schering AG.
Hypogonadism is an indication of an impaired testes function. There are various causes for reduced testosterone production, which result in a lowering of the concentration of this most important male sexual hormone in the blood. Due to the many functions of this hormone, testosterone deficiency can lead to considerable health problems and severely impair quality of life.
Testosterone deficiency may be caused by a variety of factors. Most often it is the result of congenital disturbances of the hormonal feedback regulation or of a disease of the testes; occasionally it may be due to a decrease in gonadal function in older age.