FDA Approves Bravelle (Urofollitropin) For In Vitro Fertilization
Clinical Trial Demonstrates State-of-the-Art Performance With Significantly Less Injection Site Pain Than Follistim
SUFFERN, NY -- December 23, 2002 -- Ferring Pharmaceuticals' new infertility treatment Bravelle (urofollitropin for injection, purified), approved by the U.S. Food and Drug Administration (FDA) for ovulation induction following pituitary suppression on May 6, 2002, received FDA approval today for use in in vitro fertilization (IVF). Bravelle is a highly purified, human-derived follicle-stimulating hormone (hFSH) administered by subcutaneous (SC) injection in IVF treatment cycles.
The new indication followed clinical evaluation demonstrating that Bravelle SC provides state-of-the-art performance, comparable in efficacy and safety to Follistim® SC (recombinant follitropin beta) in IVF, with significantly less injection site pain. Bravelle and Follistim were also comparable in mean number of stimulation days, number of vials used and estradiol levels measured during the treatment cycle.
"Bravelle is well suited to meet the needs of both physicians and patients," said Kenneth B. Kashkin, M.D., vice president, medical and regulatory affairs. "Physicians can feel confident that Bravelle offers the predictability and clinical performance required by today's IVF protocols, along with additional important patient benefits. In our clinical studies, patients using Bravelle reported significantly less injection site pain than those using Follistim. In addition, Bravelle is the most affordably priced product in its category, an important benefit since infertility treatment is generally not fully covered by insurance."
Follistim (follitropin beta for injection) is a registered trademark of Organon Inc.
A Human-Derived FSH Proven as Effective as Genetically Engineered FSH Bravelle was compared to Follistim in a randomized, assessor-blind, parallel group, multicenter trial in 120 patients undergoing controlled ovarian hyperstimulation for IVF. The pregnancy outcomes in patients receiving human chorionic gonadotropin (hCG) were equivalent for Bravelle SC and Follistim SC.1
A second prospective, parallel-group, multicenter, open-label trial in 118 patients undergoing controlled ovarian hyperstimulation for IVF was published in the June issue of Fertility and Sterility and showed that there were no significant differences in efficacy and safety between the treatment groups. 2
In both trials, patients experienced significantly less injection site pain with Bravelle compared with Follistim on the majority of treatment days.
Lowest Priced FSH Available
Based on wholesale acquisition cost, Bravelle is the most affordably priced product in its category, an important benefit since infertility treatment is generally not fully covered by insurance. In the two studies, patients used approximately 30 vials of medication during the treatment cycle. In this case, the projected savings with Bravelle would range from $447 to $520.
Comparison based on lowest priced package. Dollars rounded to whole numbers. Gonal-F (follitropin alfa for injection) is a registered trademark of Serono Laboratories, Inc.
Bravelle: The Natural Choice
Bravelle is a highly purified, human-derived follicle-stimulating hormone (hFSH) that is used to induce ovulation. In IVF, it is also used to control the timing of egg ripening and increase the chance of producing a substantial number of eggs. 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 6.8%), 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 grown 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
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 <http://www.ferringusa.com>.
References:
1 Data on file, Ferring Pharmaceuticals.
2 Dickey RP, Thornton M, Nichols J, Marshall DC, Fein SH, Nardi RV. Comparison of the efficacy and safety of a highly purified human follicle-stimulating hormone (Bravelle) and recombinant follitropin-beta for in vitro fertilization: a prospective, randomized study. Fertil Steril 2002 Jun;77(6): 1202-8.
SOURCE: Ferring Pharmaceuticals
