To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Luveris (Lutropin Alfa) Recommended For Approval In Europe For Female Infertility Treatment URL: http://www.pslgroup.com/dg/1DD336.htm Doctor's Guide August 15, 2000
GENEVA, SWITZERLAND -- August 15, 2000 -- Serono S.A. announced that the Committee for Proprietary Medicinal Products (CPMP) has recommended that Luveris®, recombinant human luteinizing hormone, lutropin alfa (LH), be granted marketing authorization by the European Medicines Evaluation Agency (EMEA). The CPMP is the committee responsible for providing scientific advice within the framework of the European centralized approval procedure. Luveris will be the first pure luteinizing hormone available for treatment of female infertility. Serono's Luveris 75 IU will be used in combination with a follicle-stimulating hormone (FSH), for the treatment of women with an endocrine form of infertility, characterized by a severe LH and FSH deficiency. Serono expects to receive the EMEA approval of Luveris later this year. The European launch will be a roll-out based upon local marketing authorization in the respective countries. The availability of recombinant human LH will be a major achievement in the treatment of infertility. For the first time, physicians will be able to individualize dosing of LH and FSH, offering greater treatment flexibility. It will allow them to move away from using urine-derived human menopausal gonadotropins, which actually contain only a limited amount of gonadotropins with the majority of the remaining preparation made up of non-specific urinary proteins. Due to its high purity and quality, recombinant human LH is suitable for subcutaneous injection by the patient herself. Clinical study results submitted by Serono show that Luveris is safe and effective in patients with severe LH and FSH deficiency. Recombinant human LH at a low daily dose of 75 IU, given in addition to Gonal-F (recombinant human FSH), promotes steroidogenesis (hormone production by the ovaries). Follicular development and preparation of the uterine lining (endometrium) is achieved in the majority of patients. In addition, Luveris is well tolerated. The gonadotropic hormones LH and FSH are naturally produced in the pituitary gland and play an important role in female reproduction. These hormones allow the development of a single mature ovarian follicle from which a fertilizable egg can be released during each menstrual cycle. A small proportion of women with infertility problems are diagnosed with severe LH and FSH deficiency and require the combined treatment of LH and FSH to achieve follicular development and steroidogenesis, which are essential for the establishment of pregnancy. With the approval of Gonal-F in 1995, Serono was the first company to market a product derived from recombinant DNA technology for the treatment of infertility. Gonal-F is the world's leading recombinant treatment for infertility, registered in 66 countries around the world, with 1999 sales of US$348.7 million. Serono's vision is to develop innovative products to assist patients at every stage of the reproductive cycle, from ovulation to early pregnancy. The CPMP positive opinion on Luveris takes the company one step closer to realising that vision and being the first company providing a totally recombinant gonadotropin portfolio. Related Link: Serono S.A.. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.