FDA APPROVES BRAVELLE™ (urofollitropin for injection, purified)
Tarrytown, NY, USA – May 6, 2002 –
FERRING’S NEW HUMAN-DERIVED FOLLICLE-STIMULATING HORMONE FOR INFERTILITY TREATMENT
New Highly Purified Alternative To Genetically Engineered
Infertility Treatments
Ferring Pharmaceuticals, a world leader in naturally occurring protein hormones, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Bravelle™ (urofollitropin for injection, purified), a highly purified, human-derived follicle-stimulating hormone (hFSH) for the treatment of infertility. Bravelle™, in conjunction with human chorionic gonadotropin, is indicated for ovulation induction following pituitary suppression.
“With the introduction of Bravelle™, Ferring has expanded its family of human-derived hormones to include a highly purified, well-tolerated hFSH with proven efficacy in ovulation induction, a critical step in many infertility treatment protocols,” said Wayne Anderson, president of Ferring Pharmaceuticals.
“Based on the fact that recombinant technology has shown no meaningful advantage in either efficacy or safety in the clinic, Ferring remains committed to the development of human-derived products in order to seek improvements in ovarian stimulation protocols. Ferring has submitted an application to the FDA seeking additional indications for Bravelle™ in infertility treatment. This application, which is supported by additional clinical studies, brings the total number of patients studied to 577. This application is currently under review by the FDA.”
A Human-Derived FSH Proven as Safe and Effective as Genetically Engineered FSH
Bravelle™ was compared to follitropin beta, a recombinant FSH, in a prospective, parallel group, multicenter trial in 111 oligo-anovulatory patients undergoing ovulation induction. Patients underwent pituitary suppression with a GnRH agonist prior to being randomized to Bravelle™ SC, Bravelle™ IM or follitropin beta SC. Results showed that there were no significant differences in efficacy and safety between the treatment groups.
|
Percentage of patients |
Bravelle™ SC |
Follitropin beta SC |
|
Ovulation |
96.1% |
85.7% |
|
Clinical pregnancy |
34.6% |
31.4% |
|
Continuing pregnancy |
34.6% |
28.6% |
|
Live birth |
34.6% |
17.1% |
In addition to the studies supporting the new drug application, Ferring has recently completed two Phase 3B clinical trials involving 24 centers. These trials evaluated the use of Bravelle™ together with Repronex® (mixed protocol), Ferring’s human menopausal gonadotropin, in the same syringe, in two age groups. The first study evaluated the use of a mixed protocol in 108 women ages 18 to 33 years; the second trial evaluated 120 women ages 34 to 40 years. This is the first time a prospective, systematic clinical evaluation of single daily dose mixed protocols has been conducted anywhere in the world.
Bravelle™: The Natural Choice
Bravelle™ is affordably priced, an important benefit since infertility treatment is generally not fully covered by insurance. It is available for both subcutaneous and intramuscular injection. Most patients prefer SC administration because it is more convenient and causes less discomfort.
Added Anderson, “Bravelle™ is ideally suited to meet the needs of infertility specialists and their patients by providing an affordable solution that combines human derived hormone efficacy with recombinant hormone-like purity.”
Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe Bravelle™. Like all gonadotropins, Bravelle™ is a potent substance capable of causing mild to severe adverse reactions, including ovarian hyperstimulation syndrome (incidence of 8.2%), with or without pulmonary or vascular complications, in women undergoing therapy for infertility.
Background on Human-Derived Hormones
The key differences in human-derived and genetically engineered infertility treatments are raw material sources and cost. Human-derived FSH treatments are highly purified follitropins extracted from the urine of postmenopausal women. By comparison, genetically engineered products are derived from the secretions from Chinese hamster ovary cells that are cultured in fetal calf or other mammalian serum, and approximate human hormones. Both are manufactured in compliance with extremely strict standards (including viral inactivation and confirmatory testing), but human-derived products are generally less expensive than their genetically engineered counterparts.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals, part of the Ferring Group, a privately owned, international pharmaceutical company, markets Bravelle™, Repronex® and Novarel® in the U.S. to infertility specialists and their patients. The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/gynecology and infertility.
For more information, call 1-888-337-7464 or visit www.ferringusa.com.
For more information, please contact
Marilyn Seiger
Kovak-Likly Communications
203.762.8833
mseiger@klcpr.com
Sharmi Albrechtsen
Communication Manager, Ferring International Center
+45 28 78 72 09
sharmi.albrechtsen@ferring.com