Committee for Medicinal Products for Human Use (CHMP) Recommends Granting Marketing Authorisation for FIRMAGON(R) (degarelix) for Treatment of Prostate Cancer
- New Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist Demonstrates Rapid, Long-Term Suppression of Testosterone
Ferring Pharmaceuticals received today notification that the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMEA), has adopted a positive opinion and is recommending to grant a marketing authorization for FIRMAGON(R) (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 (i),(ii) within three days in more than 96% of study patients.(ii) 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).(ii),(iii)
The Phase III study compared monthly administration of degarelix with monthly luteneising hormone releasing-hormone (LHRH) agonist leuprorelin's 7.5 mg in a 12-month randomised, open-label, parallel-group study in prostate cancer patients. In comparison to leuprorelin, degarelix suppressed serum testosterone and Prostate Specific Antigen (PSA) significantly faster. In addition, degarelix was able to sustain these low levels during the entire 12 month study.(ii)
By day 3 of the study, testosterone levels were suppressed to =0.5ng/mL in 96.1% of patients in the degarelix arms of the study compared to 0% in the leuprorelin arm. By day 14, 100% of patients in the degarelix arms achieved suppression of testosterone levels at =0.5ng/mL compared to 18.2% in the leuprorelin arm.(ii) After 14 days of treatment, PSA levels had declined in the degarelix treated patients by a median of 64%, while patients who were administered leuprorelin saw an 18% decline. Both treatments were well tolerated and showed similar side effect profiles. The most common side effects are hot flushes, injection site pain, injection site erythema, increased weight, nasopharyngitis, fatigue and back pain.
"Degarelix was discovered and developed by Ferring Pharmaceuticals and in
its pivotal Phase III study demonstrated both an immediate onset of action
and a profound long-term suppression of testosterone and PSA," commented Dr
"Our goal is always to have a fast and sustained reduction in
testosterone levels," said Mr
Ferring Pharmaceuticals plans to launch FIRMAGON(R) (degarelix) in
Degarelix went through an extensive clinical programme of more than 20 studies. All studies have found degarelix to be well tolerated and with no evidence of systemic allergic reactions.(ii),(iv),(v)
Notes to Editors
About Prostate Cancer
Prostate cancer is the most common form of cancer in men, and the second
leading cause of cancer death. In the US 218,890 new cases were estimated for
2007, with a mortality rate of 27,050. In 2005 127,490 new cases were
diagnosed in the 5 biggest European countries and 18,310 in
Degarelix is a GnRH receptor antagonist indicated for advanced prostate cancer.
Ferring is a Swiss-headquartered, research driven, speciality biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of urology, endocrinology, gastroenterology, gynaecology, and fertility. In recent years Ferring has expanded beyond its traditional European base and now has offices in over 40 countries. To learn more about Ferring or our products please visit http://www.ferring.com.
--------------------------------- (i) Van Poppel H, De La Rosette JJ, Persson B.E, Oleson TK, Degarelix Study Group; Long-term evaluation of degarelix, a gonadotrophin- releasing hormone (GnRH) receptor blocker, investigated in a multicentre randomised study in prostate cancer (CAP) patients. Abstract (23.) Euro Urol Suppl 2007;6(2):28 (ii) Boccon-Gibod L, Klotz L, Schroder FH, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK; Degarelix compared to leuprolide depot 7.5 mg in a 12-month randomised, open-label, parallel-group phase III study in prostate cancer patients. Abstract 537 presented at the 23rd EAU Congress, Milan, Italy, 2008. (iii) Nielsen S, Connolly M, Persson B, Variation between countries in the perceived use of antiandrogens to prevent flare symptoms: results of a comprehensive survey. Abstract 539 presented at the 23rd EAU Congress, Milan, Italy, 2008 (iv) Gittelman M, Pommerville P, Persson B, Olesen T, A 1-year, open label, randomised Phase II dose finding study of degarelix for the treatment of prostate cancer in North America. Journal of Urology, Vol. 180, November 2008. (v) Tammela T, Iversen P, Johansson J, Persson B, Jensen J, Olesen T. Degarelix-a phase II multicentre, randomised dose escalating study testing a novel GnRH receptor blocker in prostate cancer patients (Abstract No. 904) European Urology Supplements 4 (2005) No.3, pp 228. For further information please contact: Katie Fyfe, Tonic Life Communications, Tel: +44-207-798-9920, Katie.firstname.lastname@example.org . Monica Gounaropoulos, Tonic Life, Communications, Tel: +44-207-798-9910, Monica.email@example.com . Helen Gallagher, Ferring Pharmaceuticals, Tel: +41-58-301-0051, Helen.Gallagher@ferring.com .
SOURCE Ferring Pharmaceuticals