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
BeOne Medicines and Revolution Medicines Announce Clinical Development and Regional Commercialization Collaboration10.8.2026 12:00:00 CEST | Press release
Clinical collaboration enables novel combinations of select BeOne oncology assets with four Revolution Medicines clinical-stage RAS(ON) inhibitors for RAS-addicted cancersRegional rights agreement provides BeOne with exclusive development and commercialization rights to four Revolution Medicines clinical assets in select Asian markets BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, and Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced a multi-part collaboration including: a clinical collaboration to evaluate drug combinations incorporating select clinical-stage oncology assets from BeOne with any of Revolution Medicines’ four clinical RAS(ON) inhibitors, and a separate regional rights agreement granting BeOne exclusive development and commercialization rights to these Revolution Medicines assets in select Asian markets. Clinical
OpenGate Capital to Acquire Maersk Training, the Global Safety Training and Gas-Safety Services Business of Maersk10.8.2026 08:00:00 CEST | Press release
OpenGate Capital (“OpenGate”), a global private equity firm, announced today that it has signed a definitive agreement to acquire Maersk Training and its subsidiary Maersk H2S Safety Services. The company, a provider of global safety training and gas safety services, is being carved out from A.P. Møller - Mærsk A/S (MAERSK A:CPH), a listed integrated logistics company. Headquartered in Svendborg, Denmark, Maersk Training is a leading global provider of essential safety services that operates through two complementary business segments. The first segment, Maersk H2S Safety Services, is a specialist provider of outsourced hydrogen sulphide and Health, Safety and Environment safety services, which include onsite supervision, monitoring and safety equipment maintenance for customers in high-risk operating environments. The second segment, Training Business, is a global provider of safety training, competency development and simulation, delivered through instructor led, digital and virtual
Ant International’s Bettr Partners with Muslim Pro to Introduce Umrah Financing Service in Malaysia10.8.2026 05:49:00 CEST | Press release
Bettr, a leading provider of inclusive and embedded finance and fintech solutions under Ant International, today announced its partnership with Muslim Pro, a popular Islamic lifestyle app serving over 190 million downloads worldwide, to launch an Umrah financing solution in Malaysia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260809780047/en/ Ant International's Bettr and Muslim Pro launch an Umrah financing solution in Malaysia to help families better manage their cash flow and spread pilgrimage costs responsibly. The solution is designed for eligible Muslims who have the means to undertake the pilgrimage but prefer to spread its cost over time. This flexibility enables individuals and families to manage their cash flow responsibly, maintain regular savings and preserve sufficient liquidity for emergencies and other financial obligations. The launch marks a significant milestone in Bettr’s Islamic finance initiative and
ICC Arbitral Tribunal Issues Quantum Award for AOP Health in BESREMi® Proceedings7.8.2026 19:48:00 CEST | Press release
An ICC Arbitral Tribunal has awarded AOP Orphan Pharmaceuticals GmbH (“AOP Health”) a total of about EUR 112 Mio in a quantum award issued in the ongoing arbitration proceedings with PharmaEssentia Corp. (“PharmaEssentia”) concerning BESREMi® (ropeginterferon alfa-2b). The award quantifies AOP Health’s damage claims for PharmaEssentia’s intentional breaches at ca. EUR 82 Mio. It also awards AOP Health ca. EUR 31 Mio plus interest as reimbursement for AOP Health overpayments made to PharmaEssentia as a result of excessive pricing in the years 2019-2022. The Tribunal thereby confirmed that PharmaEssentia has been overcharging AOP Health by up to 900% over these years. The Tribunal affirmed AOP Health's valid set-off of the profit-sharing payments amount owed to PharmaEssentia of approximately EUR 17 Mio against AOP Health's substantially exceeding damages claims. This means that AOP Health shall not make any payment to PharmaEssentia. Interest on AOP Health’s claims will continue to accr
Coulson Aviation Canada Acquires 10 Former RCAF Hercules, Doubling C-130H Fleet7.8.2026 19:16:00 CEST | Press release
Canadian-led expansion will build the world’s largest and most capable C-130 airtanker fleet Coulson Aviation Canada, the Canadian division of Coulson Aviation, has acquired 10 former Royal Canadian Air Force CC-130H Hercules aircraft from the Government of Canada. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260807019094/en/ Britton Coulson, left, and Wayne Coulson stand in front of one of 10 former Royal Canadian Air Force CC-130H Hercules aircraft recently acquired by Coulson Aviation from the Government of Canada. At right is a Coulson C-130H outfitted for aerial firefighting with the company’s proprietary RADS-XXL retardant delivery system, capable of carrying up to 4,000 U.S. gallons, or more than 15,000 litres, of water or fire retardant. The acquisition doubles Coulson’s global C-130H fleet to 20 aircraft, expanding its capacity to build the world’s largest C-130 airtanker fleet. The acquisition doubles Coulson’s g
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