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FDA Approves Luveris for Concomitant Use With Gonal-f
GENEVA, Switzerland and ROCKLAND, Massachusetts, October 15 /PRNewswire-FirstCall/ -- Serono (virt-x SEO and NYSE: SRA) announced today that the US Food and Drug Administration (FDA) has approved Luveris (lutropin alfa for injection) for concomitant use with Gonal-f (follitropin alfa for injection) for stimulation of follicular development in infertile hypogonadotropic hypogonadal (HH) women with profound LH deficiency (LH
HH is a rare endocrine deficiency. Women with HH are unable to produce the hormones needed for full development of follicles in the ovaries, ovulation and growth of the lining of the uterus sufficient to support implantation of a fertilized egg and early pregnancy.
Luveris is the first and only approved recombinant human form of luteinizing hormone (LH), a naturally occurring fertility hormone. The Luveris® approval makes Serono the only company to offer three recombinant fertility hormones, part of its long-term global strategy to develop a 100% recombinant human gonadotropin portfolio. By the end of this year, Serono will complete a systematic commercial phase out of its older-generation urinary products, with the exception of Japan.
"The Luveris approval is a result of Serono's strong dedication to research and development of products in reproductive health," said Bharat Tewarie, MD, Executive Vice President, Reproductive Health, Serono, Inc. "We recognized the additional endocrine needs of this special population of patients and developed recombinant human LH specifically for them as part of our continued commitment to advancing infertility treatment." Data on Luveris are being presented at the 60th Annual Meeting of the American Society for Reproductive Medicine in Philadelphia later this month. For patients and healthcare providers who would like additional information on Luveris and other Serono products, a toll-free educational service called Fertility LifeLines (+1-866-538-7879) is available.
"Luveris, in conjunction with Gonal-f, helps individualize treatment for a special population of infertile patients," said Zev Rosenwaks, MD, Director, Center for Reproductive Medicine and Infertility at New York Weill Cornell. "It provides an option for women who specifically do not produce or secrete LH."
Luveris addresses an unmet medical need and has also received Orphan Drug designation from the FDA Office of Orphan Products Development. It is currently approved in over 60 countries worldwide, including countries in the European Union, Asia, Latin America and Australia.
Side effects may occur with the use of infertility drugs and, therefore, should only be prescribed by physicians who are thoroughly familiar with infertility problems and their management. Ovarian hyperstimulation syndrome (OHSS) with or without vascular and pulmonary complications can occur with the use of infertility drugs. Reports of multiple births have been associated with gonadotropin treatments. The most common side effects in women using Luveris include headache, abdominal pain, nausea, OHSS, breast pain, and ovarian cyst. Please see full prescribing information for product details.