Ferring's Firmagon OKed by CHMP

Switzerland's Ferring Pharmaceuticals says that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency  (EMEA) has recommended the approval of Firmagon (degarelix) for  advanced, hormone-dependent prostate cancer.

In Phase III studies, the novel gonadotrophin-releasing hormone receptor  blocker produced a significant reduction in levels of testosterone  within three days in more than 96% of study patients. Testosterone plays  a major role in the growth and spread of prostate cancer cells. The data  show that degarelix provided an extremely fast effect on testosterone  levels, close to the immediate impact achieved with surgery, Ferring  noted.

The Phase III study compared monthly administration of degarelix with  monthly 7.5mg doses of leuprorelin in a 12-month randomized, open-label,  parallel-group study in prostate cancer patients. Degarelix suppressed  serum testosterone and prostate-specific antigen significantly faster,  and was able to sustain these low levels during the entire 12-month  study, Ferring said.