THERAMEX
17.6.2022 12:45:04 CEST | Business Wire | Press release
The European Commission (EC) has granted Marketing Authorization for Yselty® (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’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, with and without additional hormonal therapy, for women suffering from UF. Yselty® is approved in the EU at the following doses:
- 100 mg or 200 mg once daily with hormonal ABT, with no limitation in treatment duration
- 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
- 200 mg once daily for short-term use (< 6 months) in clinical situations when reduction of uterine and fibroid volume is desired
The approval is based on positive data from the ObsEva’s two Phase 3 PRIMROSE trials.
“Uterine 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’s health with limited treatment options. This marks an important therapeutic extension for Theramex to widen our portfolio and provide gynaecologist’s support for unmet medical needs,” said Robert Stewart, Theramex CEO.
“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,” said Dr. Brandi Howard, Chief Clinical Officer of ObsEva. “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.”
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.
About Yselty® (linzagolix)
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.
About Theramex
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’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.
About ObsEva
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”.
For more information, please visit www.ObsEva.com
About Kissei
Linzagolix has been discovered by Central Research Laboratories of Kissei Pharmaceutical Co., Ltd. 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.” As a strong R&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.
Yselty_HQ_PRESSR_007649 D.O.P: 17/06/22
View source version on businesswire.com: https://www.businesswire.com/news/home/20220617005176/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Ant International, Mastercard and Visa Initiate Collaboration on Know-Your-Agent Interoperability to Scale Agentic Commerce10.9.2026 03:00:00 CEST | Press release
Ant International, Mastercard, and Visa have begun collaboration on a Know-Your-Agent (KYA) interoperability framework, designed to help card networks, digital wallet ecosystems, agent platforms and marketplaces streamline agent onboarding and identification across networks, based on shared principles while preserving each network's own verification and decisioning processes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909003891/en/ Ant International, Mastercard and Visa initiate collaboration on Know-Your-Agent interoperability to scale agentic commerce AI agents are evolving from making recommendations to completing purchases on behalf of users. By 2030, AI agents are projected to orchestrate US$3 trillion to 5 trillion of global consumer commercei. Underlying the mega-trend is the KYA architecture of payment networks and service providers, which establishes requirements and accountability, verifies agent identities,
Andersen Global etablerer nyt medlemsvirksomhed i Frankrig9.9.2026 23:00:00 CEST | Pressemeddelelse
Andersen Global styrker sin tilstedeværelse i Frankrig med tilføjelsen af Andersen Société d'Avocats (Andersen in France), en medlemsvirksomhed baseret i Paris, der tilbyder integrerede juridiske ydelser til klienter i Frankrig og internationalt. Andersen in France tilbyder strategiske juridiske løsninger inden for selskabsskat, international skat, transfer pricing, moms og skatteprocesser og bistår klienter over hele verden. Under ledelse af de administrerende partnere Benoît Dambre og François Morazin håndterer det tværfaglige team også specialiserede områder som byplanlægning, fast ejendom, intellektuel ejendomsret og privatlivsbeskyttelse, bæredygtighed og ESG, EU-ret og sanktioner samt andre komplekse juridiske problemstillinger. "Vi ser juridisk rådgivning som mere end blot at håndtere umiddelbare udfordringer – det bør hjælpe klienter med at træffe kvalificerede beslutninger og opsøge muligheder med selvtillid," udtalte Benoît. "At blive en del af Andersen Global giver os muligh
Cyclic Materials Opens America’s First Commercial-Scale Facility Delivering Automated Rare Earth Magnet Recovery9.9.2026 22:09:00 CEST | Press release
The Mesa, Arizona facility deploys Cyclic Materials’ proprietary technology to process up to 25,000 metric tons of magnet-bearing products annually, creating a new domestic source of rare earth elements and copper, aluminum and steel for direct reintegration into U.S. manufacturing Cyclic Materials announced today the opening of its first commercial-scale rare earth magnet recycling facility in Mesa, Arizona, marking a major milestone in building domestic supply of rare earths and critical minerals. With an annual processing capacity of up to 25,000 metric tons of magnet-bearing end-of-life products, the facility produces Cyclic’s rare earth magnet material, Mag-Xtract™, and critical minerals such as copper and aluminum, and steel. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909142592/en/ Leaders gather to mark the opening of Cyclic Materials’ new facility in Mesa, Arizona. From left to right: Herbert Flores, Arizona C
Belkin Introduces Titan SmartShield Pro Collection for the New iPhone 18 Pro Lineup9.9.2026 21:00:00 CEST | Press release
New collection combines advanced Nano-Titan protection with options for crystal-clear viewing, enhanced screen privacy and blue-to-red light conversion Belkin, a leading consumer electronics brand for over 40 years, today introduced its new Titan SmartShield Pro collection, designed to protect and enhance the experience of the new iPhone 18 Pro lineup. The collection includes three distinct screen protectors – clear, Blue-to-Red and Bright Privacy – each combining advanced Nano-Titan Technology with premium anti-reflective properties, exceptional scratch resistance and up to 9 feet of impact protection.* This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909094720/en/ Belkin Titan SmartShield Pro Blue-to-Red Light screen protector As smartphones become increasingly central to how people work, travel and connect, the Titan SmartShield Pro collection goes beyond traditional screen protection to address the different ways consum
PPAI Releases Landmark Study Showing Branded Merchandise Supports a $472 Billion Global Economic Footprint9.9.2026 19:24:00 CEST | Press release
First-of-its-kind Oxford Economics study reveals annual spending, jobs and tax contributions Branded merchandise connects brands and people every day, but its impact extends well beyond the products consumers wear, use, receive or purchase. A landmark study commissioned by Promotional Products Association International (PPAI) provides the first comprehensive look at the global economic ecosystem behind branded merchandise. Conducted by independent global advisory firm Oxford Economics, the Branded Merchandise Global Market Report measures the industry end to end, from manufacturing and decoration to distribution, retail, e-commerce, fulfillment, marketing and brand activation. Key findings: $338.3 billion was spent on branded merchandise globally in 2025. The industry supported $472.3 billion in global GDP. Branded merchandise supported 11.9 million jobs worldwide. The sector supported $141.3 billion in global tax revenues – roughly the same as the entire Swiss federal budget. “For yea
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom