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Study supports IVF indication for Bravelle.(in vitro fertilization)(urofollitropin for injection, purified)
2002 JUL 18 - (NewsRx.com & NewsRx.net) -- According to a study published in the June issue of Fertility and Sterility, Bravelle (urofollitropin for injection, purified), a highly purified human-derived follicle-stimulating hormone (hFSH), administered subcutaneously (SC) and intramuscularly (IM), is comparable in activity and tolerability to recombinant follitropin beta (Follistim SC) for in vitro fertilization (IVF).
Bravelle was approved by the U.S. Food and Drug Administration (FDA) on May 6, 2002, for ovulation induction (OI) following pituitary suppression, a common step in the treatment of infertility. These and other data supporting the use of Bravelle in IVF are currently under review by the FDA.
"This study demonstrates that in IVF, premium-priced recombinant FSH showed no advantage in activity or tolerability over Bravelle, a highly purified preparation of human-derived FSH," said Wayne Anderson, president of Ferring Pharmaceuticals. "Bravelle is ideally suited to meet the needs of infertility specialists and their patients by providing an affordable treatment that combines human-derived hormone efficacy with recombinant hormone-like purity."
Bravelle SC, Bravelle IM, and Follistim SC were compared in a randomized, open-label, parallel group, multicenter trial in 177 patients, ages 18 to 39, undergoing controlled ovarian hyperstimulation for IVF. Patients who were successfully down-regulated (achieved pituitary suppression) were randomized into three groups and received Bravelle SC (n=60), Bravelle IM (n=59) or Follistim (n=58) once daily (225 IU to a maximum of 450 IU) for up to 12 days. Subsequently, human chorionic gonadotropin (hCG) was ...
- FDA approves Bravelle for in vitro fertilization.
- Newspaper article from: Biotech Week January 22, 2003 700+ words
...indication followed clinical evaluation demonstrating that Bravelle SC provides state-of-the-art performance, comparable in...receiving human chorionic gonadotropin (hCG) were equivalent for Bravelle SC and Follistim SC.(1) Follistim on the majority of treatment...
- Study confirms effectiveness of Bravelle in producing donor eggs for IVF.
- Newspaper article from: Biotech Week March 12, 2003 700+ words
...ART)." <b>Study design</b>. Bravelle SC was tested for efficacy and safety in its ability to induce...donors, ages 21 to 33, and 39 recipients, ages 28 to 48. Bravelle SC was administered for up to 12 days in oocyte donors who were...
- FDA approves Bravelle for in vitro fertilization.(fertility drug)(Food and Drug...
- Magazine article from: Women's Health Weekly January 23, 2003 700+ words
...indication followed clinical evaluation demonstrating that Bravelle SC provides state-of-the-art performance, comparable in...receiving human chorionic gonadotropin (hCG) were equivalent for Bravelle SC and Follistim SC.(1) Follistim on the majority of treatment...