6月17日，伦敦th, 2022 – The European Commission (EC) has granted Marketing Authorization for Yselty® (linzagolix), 一种口服GnRH拮抗剂, 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’s health.
The EC decision follows the Committee for Medicinal Products for Human Use (CHMP) confirmation of positive opinion in April 2022.
Linzagolix ® is the only approved oral GnRH antagonist to offer flexible dosing options, 有或没有额外的激素治疗, 对于患有UF的女性来说. Yselty®在欧盟获得批准，剂量如下:
The approval is based on positive data from the ObsEva’s two Phase 3 PRIMROSE trials.
“25%的育龄妇女患有子宫肌瘤, 许多人症状严重，需要手术. 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. 另外, we will continue to work with our partner ObsEva for follow-on indications, 比如子宫内膜异位症, 这是妇女健康的另一个治疗选择有限的领域. This marks an important therapeutic extension for Theramex to widen our portfolio and provide gynaecologist’s support for unmet medical needs,罗伯特·斯图尔特说, Theramex首席执行官.
“As the first and only approved GnRH antagonist to provide flexible dosing options with and without hormonal add-back therapy, Yselty® has the potential to transform the treatment paradigm and significantly advance medical options for women in the EU with uterine fibroids,博士说. 布兰迪·霍华德，ObsEva的首席临床官. “We 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.”
2022年2月, Theramex与Obseva签订了一项战略许可协议, 在新型疗法领域领先的生物制药公司, to commercialize and market the introduction of linzagolix across international markets outside of the U.S.加拿大和亚洲.
Linzagolix是每天一次, 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.
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, 生育能力, 更年期和骨质疏松症. Theramex’s commitment is to listen to and understand its patients, serve their needs and offer healthcare solutions to help improve their lives. Theramex’s 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.
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ObsEva is a biopharmaceutical company developing and commercializing novel therapies to help improve women’s reproductive health and pregnancy. The Company’s first approved drug is Yselty® (linzagolix), which is approved in the EU. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is traded under the ticker symbol “OBSN”.
Linzagolix has been discovered by Central Research Laboratories of Kissei Pharmaceutical Co.有限公司. Kissei is a Japanese pharmaceutical company based on the management philosophy “contributing to society through high-quality, innovative pharmaceutical products” and “serving society through our employees.作为一个强R&D-oriented公司, it concentrates on providing innovative pharmaceuticals to patients worldwide in the focus fields of urology, 肾脏学/透析, 妇科和罕见/难治性疾病.