In Phase III studies, degarelix 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 effect achieved with surgery. The European Commission approval for Firmagon (degarelix) follows approval from the FDA in the US in December 2008.
Ferring plans to communicate a range of information about the treatment at the European Academy of Urology (EAU) congress in Stockholm in March.
Pascal Danglas, executive vice president of clinical and product development at Ferring Pharmaceuticals, said: We are delighted with the approval of Firmagon, which demonstrated in clinical trials both an immediate onset of action and a profound long-term suppression of testosterone and prostate specific antigen. We will work with local authorities to ensure the launch of Firmagon to patients across EU countries as soon as possible.