Ferring Pharmaceuticals announced that it has received marketing
authorisation from the European Commission, 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)
"We are delighted with the approval of FIRMAGON(R) (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(R) (degarelix) follows
approval from the FDA in the US in December 2008.
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 Japan.
About degarelix
Degarelix is a GnRH receptor antagonist indicated for advanced prostate
cancer. Ferring plans to communicate a range of information about the
treatment at the European Academy of Urology (EAU) congress in Stockholm in
March.
About Ferring
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 45 countries. To learn more about Ferring or our products please
visit ferring
(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, Schröder 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
Ferring Pharmaceuticals
View drug information on Degarelix.