FDA has approved the trade name Firmagon for degarelix for injection, a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of advanced prostate cancer.
“This treatment was in development by Ferring Pharmaceuticals in the U.S. and Europe for more than a decade,” said the company’s President and CEO, Wayne Anderson “We launched degarelix prior to receiving approval for its brand name in order to bring the medical community an effective alternative in the treatment of advanced prostate cancer without delay.”
Degarelix provides fast, long-term suppression of testosterone, a hormone that stimulates prostate cancer growth, according to Ferring. Phase 3 pivotal studies showed that the medication is as effective as leuprolide in reducing and sustaining castrate levels of testosterone, the company said. In addition, suppression of testosterone to castrate levels occurred significantly faster in patients receiving degarelix than in those receiving leuprolide.
In studies, degarelix recipients achieved a 90% decrease in median testosterone levels at Day 3 of treatment compared with a 65% increase in leuprolide-treated patients. Additionally, degarelix was as effective as leuprolide in suppressing testosterone levels from Day 28 to the end of the study (Day 364), with 97.2% of the degarelix group maintaining medical castration levels compared with 96.4% for leuprolide recipients.
Degarelix has been used by more than 3,000 patients since being introduced to the market, according to Ferring.