{"id":2181,"date":"2022-06-17T14:23:07","date_gmt":"2022-06-17T13:23:07","guid":{"rendered":"https:\/\/pprd.theramex.com\/pt\/?p=2181"},"modified":"2022-06-17T14:23:07","modified_gmt":"2022-06-17T13:23:07","slug":"theramex-announces-european-commission-marketing-authorization-for-yselty-linzagolix-an-oral-gnrh-antagonist-for-the-treatment-of-symptoms-of-uterine-fibroids","status":"publish","type":"post","link":"https:\/\/www.theramex.com\/pt\/novidades\/theramex-announces-european-commission-marketing-authorization-for-yselty-linzagolix-an-oral-gnrh-antagonist-for-the-treatment-of-symptoms-of-uterine-fibroids\/","title":{"rendered":"Theramex Announces European Commission Marketing Authorization for Yselty\u00ae (linzagolix), an Oral GnRH Antagonist, for the treatment of symptoms of Uterine Fibroids"},"content":{"rendered":"\n<p><strong>For Media and Investors only<\/strong><\/p>\n\n\n\n<p><strong>London, June 17<sup>th<\/sup>, 2022 \u2013 <\/strong>The European Commission&nbsp;(EC) has granted Marketing Authorization for Yselty\u00ae (linzagolix), an oral GnRH antagonist, indicated for the treatment of moderate to severe symptoms of Uterine Fibroids (UF) in adult women (over 18 years of age) of reproductive age. This announcement is in partnership with ObsEva SA (Nasdaq: OBSV), a biopharmaceutical company developing and commercializing novel therapies for women\u2019s health. <\/p>\n\n\n\n<p>The EC decision follows the Committee for Medicinal Products for Human Use (CHMP) confirmation of positive opinion in April 2022.<\/p>\n\n\n\n<p>Linzagolix \u00ae is the only approved oral GnRH antagonist to offer flexible dosing options, with and without additional hormonal therapy, for women suffering from UF. Yselty\u00ae is approved in the EU at the following doses:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>100 mg or 200 mg once daily with hormonal ABT, with no limitation in treatment duration<\/li>\n\n\n\n<li>100 mg once daily for women in whom ABT is not recommended or who prefer to avoid hormonal therapy, with no limitation in treatment duration<\/li>\n\n\n\n<li>200 mg once daily for short-term use (&lt; 6 months) in clinical situations when reduction of uterine and fibroid volume is desired<\/li>\n<\/ul>\n\n\n\n<p>The approval is based on positive data from the ObsEva\u2019s two Phase 3 PRIMROSE trials.<\/p>\n\n\n\n<p>\u201cUterine Fibroids affect 25% of women within reproductive age, many with severe symptoms requiring surgery. With the approval of Linzagolix we can potentially offer a new treatment option for physicians in managing women with uterine fibroids to provide symptomatic relief and delay or avoid surgery. Additionally, we will continue to work with our partner ObsEva for follow-on indications, such as endometriosis, another area of women\u2019s health with limited treatment options. This marks an important therapeutic extension for Theramex to widen our portfolio and provide gynaecologist\u2019s support for unmet medical needs,\u201d said Robert Stewart, Theramex CEO.<\/p>\n\n\n\n<p>\u201cAs the first and only approved GnRH antagonist to provide flexible dosing options with and without hormonal add-back therapy, Yselty\u00ae has the potential to transform the treatment paradigm and significantly advance medical options for women in the EU with uterine fibroids,\u201d said Dr. Brandi Howard, Chief Clinical Officer of ObsEva. \u201cWe are pleased to be the first to provide women and doctors with a non-hormonal dosing option for the millions of women who either have contraindications to or a personal preference to avoid the use of hormonal add-back therapy, while also providing dosing options for women for whom hormonal add-back therapy is appropriate.\u201d<\/p>\n\n\n\n<p>In February 2022, Theramex entered into a strategic licensing agreement with Obseva, a leading biopharmaceutical company in novel therapies, to commercialize and market the introduction of linzagolix across international markets outside of the U.S., Canada, and Asia.<\/p>\n\n\n\n<p><strong>About Yselty\u00ae (linzagolix)<\/strong><br>Linzagolix is a once daily, oral GnRH receptor antagonist developed to offer flexible dosing options with and without hormonal add-back therapy to women suffering from uterine fibroids and is approved in the EU.<\/p>\n\n\n\n<p><strong>About Theramex<\/strong><\/p>\n\n\n\n<p>Theramex is a leading global speciality pharmaceutical company dedicated to women and their health. Theramex supports women at different stages of their lives by providing a broad portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis. Theramex\u2019s commitment is to listen to and understand its patients, serve their needs and offer healthcare solutions to help improve their lives. Theramex\u2019s vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing patient-focused and effective solutions that care for and support women through different stages of their life.<\/p>\n\n\n\n<p><strong>For further information, please contact:<\/strong><br><a href=\"mailto:CommunicationsPR@Theramex.com\">CommunicationsPR@Theramex.com<\/a><br>+44 203 962 5555<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><br><strong>About Obseva<\/strong><br>ObsEva is a biopharmaceutical company developing and commercializing novel therapies to help improve women\u2019s reproductive health and pregnancy. The Company\u2019s first approved drug is Yselty\u00ae (linzagolix), which is approved in the EU. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol \u201cOBSV\u201d and on the SIX Swiss Exchange where it is traded under the ticker symbol \u201cOBSN\u201d.<\/p>\n\n\n\n<p>For more information, please visit <a href=\"http:\/\/www.ObsEva.com\">www.ObsEva.com<\/a><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>About Kissei<\/strong><br><br>Linzagolix has been discovered by Central Research Laboratories of Kissei Pharmaceutical Co., Ltd. Kissei is a Japanese pharmaceutical company based on the management philosophy \u201ccontributing to society through high-quality, innovative pharmaceutical products\u201d and \u201cserving society through our employees.\u201d As a strong R&amp;D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide in the focus fields of urology, nephrology\/dialysis, gynaecology and rare\/intractable diseases.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>For Media and Investors only London, June 17th, 2022 \u2013 The European Commission&nbsp;(EC) has granted Marketing Authorization for Yselty\u00ae (linzagolix), an oral GnRH antagonist, indicated for the treatment of moderate to severe symptoms of Uterine Fibroids (UF) in adult women (over 18 years of age) of reproductive age. This announcement is in partnership with ObsEva [&hellip;]<\/p>\n","protected":false},"author":31,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-2181","post","type-post","status-publish","format-standard","hentry","category-uncategorised"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Theramex Announces European Commission Marketing Authorization for Yselty\u00ae (linzagolix), an Oral GnRH Antagonist, for the treatment of symptoms of Uterine Fibroids - Theramex Portugal<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.theramex.com\/pt\/novidades\/theramex-announces-european-commission-marketing-authorization-for-yselty-linzagolix-an-oral-gnrh-antagonist-for-the-treatment-of-symptoms-of-uterine-fibroids\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Theramex Announces European Commission Marketing Authorization for Yselty\u00ae (linzagolix), an Oral GnRH Antagonist, for the treatment of symptoms of Uterine Fibroids - Theramex Portugal\" \/>\n<meta property=\"og:description\" content=\"For Media and Investors only London, June 17th, 2022 \u2013 The European Commission&nbsp;(EC) has granted Marketing Authorization for Yselty\u00ae (linzagolix), an oral GnRH antagonist, indicated for the treatment of moderate to severe symptoms of Uterine Fibroids (UF) in adult women (over 18 years of age) of reproductive age. 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