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news.Switzerland-based Ferring Pharmaceuticals has received notification that the Committee for Medicinal Products for Human Use, part of the European Medicines Agency, has adopted a positive opinion and is recommending to grant a marketing authorization for Firmagon, a new GnRH receptor antagonist indicated for patients with advanced, hormone-dependent prostate cancer.
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In Phase III studies Firmagon (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).
The Phase III study compared monthly administration of degarelix with monthly luteneising hormone releasing-hormone agonist leuprorelin’s 7.5mg in a 12-month randomized, open-label and parallel-group study in prostate cancer patients. In comparison to leuprorelin, degarelix suppressed serum testosterone and prostate specific antigen significantly faster. In addition, degarelix was able to sustain these low levels during the entire 12 month study, the company said.
Ferring Pharmaceuticals plans to launch Firmagon in Europe in the first quarter of 2009 and is also awaiting an imminent FDA decision on approval for commercialization in the US. It is expected that commercialization in other key global markets will follow during 2009 and 2010 once approval is received from the relevant local regulatory authorities.
Michel Pettigrew, COO of Ferring Pharmaceuticals, said: The recommendation from the European Medicines Agency to grant marketing authorization for Firmagon is a significant milestone for Ferring. It is the first positive opinion we have received from a regulatory authority for Firmagon which, in turn, will be the first product that Ferring will launch on a global basis.