CardiovascularFerring Pharmaceuticals Announces Trade Name Firmagon (Degarelix ForInjection) For Advanced Prostate Cancer Treatment
Ferring Pharmaceuticals announced yesterday that the U.S.
Food and Drug Administration (FDA) has approved the trade name FIRMAGON (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)* 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.
About FIRMAGON
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 hormonereleasing
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 gammaglutamyltransferase
(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 ( Ferring Pharmaceuticals Inc.