PARSIPPANY, N.J., Aug. 4 /PRNewswire/ -- Ferring Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved the trade name FIRMAGON(R) (degarelix for injection) for its prostate cancer treatment previously marketed under the generic name degarelix. FIRMAGON is a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for patients with advanced prostate cancer. Since initial market introduction under the generic name degarelix, FIRMAGON has been used by more than 3,000 patients to fight their prostate cancer.
"This treatment was in development by Ferring Pharmaceuticals in the U.S. and Europe for more than a decade," said Wayne Anderson, President and CEO of Ferring Pharmaceuticals Inc., USA. "We launched degarelix prior to receiving approval for its brand name in order to bring the medical community an effective alternative in the treatment of advanced prostate cancer without delay. We plan to continue our research in the area of urology and we expect to introduce additional treatment advances in the future."
FIRMAGON provides fast, long-term suppression of testosterone, a hormone that stimulates prostate cancer growth.(1-3) Phase III pivotal studies showed that FIRMAGON is as effective as leuprolide (Lupron Depot(R))* in reducing and sustaining castrate levels of testosterone.(1,2) Suppression of testosterone to castrate levels occurred significantly faster in patients receiving FIRMAGON than in those receiving leuprolide.(1,2) At Day 3 of treatment, the FIRMAGON group achieved a 90 percent decrease in median testosterone levels compared with the leuprolide group, which experienced a 65 percent increase in median testosterone levels, a statistically significant result. FIRMAGON was as effective as leuprolide in suppressing testosterone levels from Day 28 to the end of the study (Day 364), with 97.2 percent of the FIRMAGON patients maintaining medical castrate levels compared with 96.4 percent for leuprolide.
In addition, prostate-specific antigen (PSA) levels were lowered by 64 percent two weeks after administration of FIRMAGON, 85 percent after one month, 95 percent after three months, and remained suppressed throughout the one year of treatment.(1,2) These PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline is related to a clinical benefit.
FIRMAGON is the exact same product as degarelix and carries the same National Drug Code (NDC). FIRMAGON is being reimbursed by all Medicare Administrative Carriers and virtually all commercial insurers. A free reimbursement assistance hotline for FIRMAGON is available at 1-877-971-3778 and has already assisted hundreds of patients and physician offices. Centers for Medicare & Medicaid Services (CMS) reimbursement rates are on their Web site and can be accessed at http://tinyurl.com/kl79hr. For complete prescribing information, visit www.FIRMAGON.com.
FIRMAGON is an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced prostate cancer. As a receptor antagonist, FIRMAGON reversibly binds to the GnRH receptors in the pituitary gland, immediately suppressing the secretion of the luteinizing hormone (LH), follicle-stimulating hormone (FSH), and subsequently, testosterone levels.(4) FIRMAGON also reduces levels of prostate-specific antigen (PSA). Unlike luteinizing hormone-releasing hormone (LHRH) agonists, such as leuprolide, an established treatment for prostate cancer, FIRMAGON does not induce an initial testosterone surge. FIRMAGON is administered monthly by subcutaneous injection. The starting dose is 240 mg, followed by monthly maintenance doses of 80 mg. FIRMAGON is available for order through traditional and specialty pharmacy distributors. The average monthly cost of one year of FIRMAGON treatment is comparable to other hormone treatments for prostate cancer.
The most commonly observed adverse reactions during FIRMAGON therapy included injection site reactions (e.g. pain, erythema, swelling or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). Ninety-nine percent of these observed adverse reactions were Grade 1 or 2 (mild to moderate). Specifically relating to the injection site adverse reactions, most were transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%). Grade 3 (severe) injection site reactions occurred in two percent or less of patients receiving FIRMAGON.
FIRMAGON is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components. FIRMAGON is not indicated in women or pediatric patients. Long-term androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications.
About Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of infertility, urology, and orthopaedic products in the U.S. market. They include: BRAVELLE(R) (urofollitropin for injection, purified), MENOPUR(R) and REPRONEX(R) (menotropins for injection, USP), NOVAREL(R) (chorionic gonadotropin for injection, USP), ENDOMETRIN(R) (progesterone) Vaginal Insert, 100 mg, FIRMAGON(R) (degarelix for injection), PROSED(R) DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA(R) (1% sodium hyaluronate).
Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, orthopaedics, gastroenterology, obstetrics/gynecology, and infertility. For more information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com.
*Lupron Depot(R) (leuprolide acetate for depot suspension) is a registered trademark of TAP Pharmaceuticals Inc.
(1) Degarelix [prescribing information]. Parsippany, NJ: Ferring Pharmaceuticals Inc.; December 2008.
(2) Klotz L, Boccon-Gibod L, Shore ND, et al. The efficacy and safety of degarelix: a 12-month comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008;102(11):1531-1538.
(3) Van Poppel H, Tombal B, de la Rosette JJ, Persson B-E, Jensen J-K, Olesen TK. Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker -- results from a 1-yr, multicentre, randomised phase 2 dosage-finding study in the treatment of prostate cancer. Eur Urol. 2008;54(4):805-813.
(4) Doehn C. Immunotherapy of Prostate Cancer. Eur Urol. (2006);53-4:681-683.
|SOURCE Ferring Pharmaceuticals Inc.|
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