FDA just approved th first gonsdotropin-releasing hormone (GnRH) drug for the treatment of Advanced Prostate Cancer. This newly approved gonadotropin-releasing hormone (GnRH) receptor antagonist demonstrates rapid, long-term suppression of testosterone.
Ferring Pharmaceuticals, USA (FP) received approval from the U.S. Food and Drug Administration (FDA) for degarelix, (generic name) which is a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist used for the treatment of advanced prostate cancer. At this time the FDA is still working with PFP to develop a trade name. Assoon as a name has been decided FP says that it will immediately begin commercialization of the new drug. The Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMEA), has also recommended granting a marketing authorization for degarelix in Europe .
In the phase III studies degarelix demonstrated that it is at least as effective as leuprolide (Lupron Depot(R)) in sustaining castrate levels or lower of testosterone, and had a statistically significant faster reduction of testosterone. At Day 3 of treatment, 96% of degarelix patients achieved castrate levels of testosterone, compared with zero percent receiving leuprolide. By Day 14, 99% of