{"id":22751,"date":"2002-05-06T08:42:59","date_gmt":"2002-05-06T08:42:59","guid":{"rendered":"https:\/\/corporate.webfactory.ferring.tech\/?p=22751"},"modified":"2021-05-10T19:44:51","modified_gmt":"2021-05-10T18:44:51","slug":"fda-approves-bravelle-urofollitropin-for-injection-purified","status":"publish","type":"post","link":"https:\/\/www.ferring.com\/fda-approves-bravelle-urofollitropin-for-injection-purified\/","title":{"rendered":"FDA APPROVES BRAVELLE\u2122 (urofollitropin for injection, purified)"},"content":{"rendered":"[spb_boxed_content type=&#8221;coloured&#8221; box_link_target=&#8221;_self&#8221; padding_vertical=&#8221;0&#8243; padding_horizontal=&#8221;0&#8243; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;]\n<h2 style=\"color: #0088ce\">FDA APPROVES BRAVELLE\u2122 (urofollitropin for injection, purified)<\/h2>\n[\/spb_boxed_content] [spb_blank_spacer height=&#8221;30px&#8221; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;] [spb_boxed_content type=&#8221;coloured&#8221; box_link_target=&#8221;_self&#8221; padding_vertical=&#8221;0&#8243; padding_horizontal=&#8221;0&#8243; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;]\n<h3 style=\"color: #0088ce\">Tarrytown, NY, USA \u2013 May 6, 2002 \u2013<\/h3>\n<p>FERRING&#8217;S NEW HUMAN-DERIVED FOLLICLE-STIMULATING HORMONE FOR INFERTILITY TREATMENT<\/p>\n<h3 style=\"color: #0088ce\">New Highly Purified Alternative To Genetically Engineered<br \/>\nInfertility Treatments<\/h3>\n<p>Ferring Pharmaceuticals, a world leader in naturally occurring protein hormones, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Bravelle\u2122 (urofollitropin for injection, purified), a highly purified, human-derived follicle-stimulating hormone (hFSH) for the treatment of infertility. Bravelle\u2122, in conjunction with human chorionic gonadotropin, is indicated for ovulation induction following pituitary suppression.<\/p>\n<p>&#8220;With the introduction of Bravelle\u2122, Ferring has expanded its family of human-derived hormones to include a highly purified, well-tolerated hFSH with proven efficacy in ovulation induction, a critical step in many infertility treatment protocols,&#8221; said Wayne Anderson, president of Ferring Pharmaceuticals.<\/p>\n<p>&#8220;Based on the fact that recombinant technology has shown no meaningful advantage in either efficacy or safety in the clinic, Ferring remains committed to the development of human-derived products in order to seek improvements in ovarian stimulation protocols. Ferring has submitted an application to the FDA seeking additional indications for Bravelle\u2122 in infertility treatment. This application, which is supported by additional clinical studies, brings the total number of patients studied to 577. This application is currently under review by the FDA.&#8221;<\/p>\n<h3 style=\"color: #0088ce\">A Human-Derived FSH Proven as Safe and Effective as Genetically Engineered FSH<\/h3>\n<p>Bravelle\u2122 was compared to follitropin beta, a recombinant FSH, in a prospective, parallel group, multicenter trial in 111 oligo-anovulatory patients undergoing ovulation induction. Patients underwent pituitary suppression with a GnRH agonist prior to being randomized to Bravelle\u2122 SC, Bravelle\u2122 IM or follitropin beta SC. Results showed that there were no significant differences in efficacy and safety between the treatment groups.<\/p>\n[\/spb_boxed_content] [spb_blank_spacer height=&#8221;30px&#8221; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;] [spb_boxed_content type=&#8221;coloured&#8221; box_link_target=&#8221;_self&#8221; padding_vertical=&#8221;0&#8243; padding_horizontal=&#8221;0&#8243; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;]\n<table class=\"t1\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td class=\"td1\" valign=\"middle\">\n<p class=\"p3\">Percentage of patients<br \/>\nachieving:<\/p>\n<\/td>\n<td class=\"td2\" valign=\"middle\">\n<p class=\"p3\">Bravelle\u2122 SC<br \/>\n(n=26)<\/p>\n<\/td>\n<td class=\"td3\" valign=\"middle\">\n<p class=\"p3\">Follitropin beta SC<br \/>\n(N=35)<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"td1\" valign=\"middle\">\n<p class=\"p3\">Ovulation<\/p>\n<\/td>\n<td class=\"td2\" valign=\"middle\">\n<p class=\"p3\">96.1%<\/p>\n<\/td>\n<td class=\"td3\" valign=\"middle\">\n<p class=\"p3\">85.7%<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"td1\" valign=\"middle\">\n<p class=\"p3\">Clinical pregnancy<\/p>\n<\/td>\n<td class=\"td2\" valign=\"middle\">\n<p class=\"p3\">34.6%<\/p>\n<\/td>\n<td class=\"td3\" valign=\"middle\">\n<p class=\"p3\">31.4%<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"td1\" valign=\"middle\">\n<p class=\"p3\">Continuing pregnancy<\/p>\n<\/td>\n<td class=\"td2\" valign=\"middle\">\n<p class=\"p3\">34.6%<\/p>\n<\/td>\n<td class=\"td3\" valign=\"middle\">\n<p class=\"p3\">28.6%<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"td1\" valign=\"middle\">\n<p class=\"p3\">Live birth<\/p>\n<\/td>\n<td class=\"td2\" valign=\"middle\">\n<p class=\"p3\">34.6%<\/p>\n<\/td>\n<td class=\"td3\" valign=\"middle\">\n<p class=\"p3\">17.1%<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/spb_boxed_content] [spb_blank_spacer height=&#8221;30px&#8221; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;] [spb_boxed_content type=&#8221;coloured&#8221; box_link_target=&#8221;_self&#8221; padding_vertical=&#8221;0&#8243; padding_horizontal=&#8221;0&#8243; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;]\n<p>In addition to the studies supporting the new drug application, Ferring has recently completed two Phase 3B clinical trials involving 24 centers. These trials evaluated the use of Bravelle\u2122 together with Repronex\u00ae (mixed protocol), Ferring&#8217;s human menopausal gonadotropin, in the same syringe, in two age groups. The first study evaluated the use of a mixed protocol in 108 women ages 18 to 33 years; the second trial evaluated 120 women ages 34 to 40 years. This is the first time a prospective, systematic clinical evaluation of single daily dose mixed protocols has been conducted anywhere in the world.<\/p>\n<h3 style=\"color: #0088ce\">Bravelle\u2122: The Natural Choice<\/h3>\n<p>Bravelle\u2122 is affordably priced, an important benefit since infertility treatment is generally not fully covered by insurance. It is available for both subcutaneous and intramuscular injection. Most patients prefer SC administration because it is more convenient and causes less discomfort.<\/p>\n<p>Added Anderson, &#8220;Bravelle\u2122 is ideally suited to meet the needs of infertility specialists and their patients by providing an affordable solution that combines human derived hormone efficacy with recombinant hormone-like purity.&#8221;<\/p>\n<p>Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe Bravelle\u2122. Like all gonadotropins, Bravelle\u2122 is a potent substance capable of causing mild to severe adverse reactions, including ovarian hyperstimulation syndrome (incidence of 8.2%), with or without pulmonary or vascular complications, in women undergoing therapy for infertility.<\/p>\n<h3 style=\"color: #0088ce\">Background on Human-Derived Hormones<\/h3>\n<p>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 cultured 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.<\/p>\n<h3 style=\"color: #0088ce\">About Ferring Pharmaceuticals<\/h3>\n<p class=\"p1\"><em>Ferring Pharmaceuticals, part of the Ferring Group, a privately owned, international pharmaceutical company, markets Bravelle\u2122, Repronex\u00ae and Novarel\u00ae in the U.S. to infertility specialists and their patients.\u00a0 The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics\/gynecology and infertility.<\/em><\/p>\n<p class=\"p1\">For more information, call 1-888-337-7464 or visit <a href=\"http:\/\/www.ferringusa.com\/\">www.ferringusa.com<\/a>.<\/p>\n[\/spb_boxed_content] [spb_blank_spacer height=&#8221;30px&#8221; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;] [spb_blank_spacer height=&#8221;30px&#8221; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;] [spb_boxed_content type=&#8221;coloured&#8221; box_link_target=&#8221;_self&#8221; padding_vertical=&#8221;0&#8243; padding_horizontal=&#8221;0&#8243; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;]\n<h3 style=\"color: #0088ce\">For more information, please contact<\/h3>\n<p><strong>Marilyn Seiger<br \/>\n<\/strong><em>Kovak-Likly Communications<br \/>\n<\/em>203.762.8833<br \/>\n<span class=\"antispam\"><a href=\"mailto:mseiger@klcpr.com\">mseiger@klcpr.com<\/a><\/span><\/p>\n<p><strong>Sharmi Albrechtsen<br \/>\n<\/strong><em>Communication Manager, Ferring International Center<br \/>\n<\/em>+45 28 78 72 09<br \/>\n<span class=\"antispam\"><a href=\"mailto:sharmi.albrechtsen@ferring.com\">sharmi.albrechtsen@ferring.com<\/a><\/span><\/p>\n[\/spb_boxed_content] [spb_blank_spacer height=&#8221;30px&#8221; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;] [spb_row element_name=&#8221;Row&#8221; wrap_type=&#8221;content-width&#8221; parallax_image_height=&#8221;content-height&#8221; parallax_image_movement=&#8221;fixed&#8221; parallax_image_speed=&#8221;0.5&#8243; bg_video_loop=&#8221;yes&#8221; parallax_video_height=&#8221;window-height&#8221; parallax_video_overlay=&#8221;none&#8221; row_overlay_opacity=&#8221;0&#8243; row_col_pos=&#8221;default&#8221; minimize_row=&#8221;no&#8221; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;] [spb_button button_text=&#8221;READ MORE PRESS RELEASES&#8221; button_size=&#8221;standard&#8221; button_colour=&#8221;accent&#8221; button_type=&#8221;standard&#8221; rounded=&#8221;no&#8221; button_dropshadow=&#8221;no&#8221; button_link=&#8221;\/media\/press-releases\/&#8221; button_target=&#8221;_self&#8221; align=&#8221;center&#8221; animation=&#8221;none&#8221; animation_delay=&#8221;0&#8243; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;] [\/spb_row]\n","protected":false},"excerpt":{"rendered":"<p>[spb_boxed_content type=&#8221;coloured&#8221; box_link_target=&#8221;_self&#8221; padding_vertical=&#8221;0&#8243; padding_horizontal=&#8221;0&#8243; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;] FDA APPROVES BRAVELLE\u2122 (urofollitropin for injection, purified) [\/spb_boxed_content] [spb_blank_spacer height=&#8221;30px&#8221; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;] [spb_boxed_content type=&#8221;coloured&#8221; box_link_target=&#8221;_self&#8221; padding_vertical=&#8221;0&#8243; padding_horizontal=&#8221;0&#8243; width=&#8221;1\/1&#8243; el_position=&#8221;first last&#8221;] Tarrytown, NY, USA \u2013 May 6, 2002 \u2013 FERRING&#8217;S NEW HUMAN-DERIVED FOLLICLE-STIMULATING HORMONE FOR INFERTILITY TREATMENT New Highly Purified Alternative To Genetically Engineered Infertility Treatments Ferring Pharmaceuticals, a world leader in [&hellip;]<\/p>\n","protected":false},"author":2410,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[259],"tags":[],"class_list":["post-22751","post","type-post","status-publish","format-standard","hentry","category-press-release-2002"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.3 (Yoast SEO v23.3) - 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