Urofollitropin - Ferring: FERRING hFSH, hFSH - Ferring, human follicle-stimulating hormone - Ferring, Bravelle.

Abstract

Ferring Pharmaceuticals (US) is developing a highly purified form of urofollitropin [human follicle-stimulating hormone, hFSH, FERRING hFSH, Bravelle] for use in ovarian stimulation in fertility treatments. The highly purified human-derived follicle-stimulating hormone (HP-FSH), administered by either intramuscular (IM) or subcutaneous (SC) injection, was in phase III trials in the US and in May 2002 the product received US FDA approval for use in conjunction with human chorionic gonadotropin for infertility patients undergoing ovulation induction. The product will be marketed as Bravelle. Ferring Pharmaceuticals has also submitted a New Drug Application for additional indications for Bravelle in infertility treatment, which is currently under review by the US FDA. Bravelle is produced from the urine of menopausal women and has been shown to be as effective as Organon's recombinant FSH product, Follistam. Preclinical studies have shown that Ferring Pharmaceuticals' hFSH can be mixed in the same syringe as purified human menopausal gonadotropin (hMG) to reduce the number of daily injections required in ovarian stimulation protocols without altering the bioactivity of FSH or luteinising hormone. In addition, Ferring Pharmaceuticals' hFSH administered SC or IM showed positive results compared with SC Repronex in a randomised, open-label study in patients undergoing in vitro fertilisation.Ferring Pharmaceuticals has teamed up with the American Infertility Association and RESOLVE: the National Infertility Association to improve access to infertility treatment in the US, with the recent launch of the 'Bravelle' HEART (Helping Expand Access to Reproductive Therapy) Programme. The programme is intended to provide urofollitropin treatment at significant cost savings to patients and their physicians. Serono is also developing a highly purified urofollitropin product.

• Journal: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy (BioDrugs) Vol. 17 Issue 4 Pg. 288-9 ( 2003) ISSN: 1173-8804 [Print] New Zealand
• PMID: 12899646 (Publication Type: Comparative Study, Journal Article)

Chemical References

• Drug Combinations
• Fertility Agents, Female
• Menotropins
• Follicle Stimulating Hormone

Topics

• Adolescent
• Adult
• Clinical Trials, Phase II as Topic
• Drug Administration Schedule
• Drug Approval
• Drug Combinations
• Female
• Fertility Agents, Female (administration & dosage, pharmacokinetics, therapeutic use)
• Fertilization in Vitro (drug effects, methods)
• Follicle Stimulating Hormone (chemistry, pharmacology, therapeutic use)
• Humans
• Infertility (drug therapy)
• Injections, Intramuscular
• Injections, Subcutaneous
• Menotropins (administration & dosage, pharmacology)
• Ovary (drug effects)
• Pregnancy
• Pregnancy Rate
• Premenopause (drug effects)
• United States
• United States Food and Drug Administration