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Ferring Pharmaceuticals announced today that it has received marketing authorisation from the European Commission, for Firmagon (degarelix), a new GnRH receptor antagonist indicated for patients with advanced, hormone-dependent prostate cancer.
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 (orchidectomy).
“We are delighted with the approval of Firmagon (degarelix), which demonstrated in clinical trials both an immediate onset of action and a profound long-term suppression of testosterone and PSA”, commented Dr Pascal Danglas, executive vice president Clinical & Product Development at Ferring Pharmaceuticals.
“We will work with local authorities to ensure the launch of Firmagon to patients across European Union countries as soon as possible.”
The European Commission approval for Firmagon (degarelix) follows approval from the FDA in the US in December 2008.