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
Garvan Institute of Medical Research Joins Parse Biosciences’ Certified Service Provider Network15.7.2026 22:00:00 CEST | Press release
Researchers across Asia-Pacific gain a new option for high-quality single cell sequencing through Garvan's Evercode WT services Parse Biosciences, a QIAGEN company, and the leader in scalable and accessible single cell sequencing, today announced that the Genomics Platform Core Facility within the Garvan Institute of Medical Research has joined its Certified Service Provider (CSP) Program. The partnership broadens access to high-quality, scalable single cell sequencing across Australia, the wider Asia-Pacific region, and beyond. Garvan is one of Australia's preeminent medical research institutions, with the Genomics Platform having deep experience in cell sorting, capture, and sequencing. As a Certified Service Provider, Garvan will offer Parse's Evercode WT kits to researchers across the region. "We see a growing number of requests for Parse projects and find the technology easy to implement and run, generating great data," said Chris O'Keeffe, Cellular Genomics Lead at the Garvan Ins
Grafana Labs Named a Leader in 2026 Gartner® Magic Quadrant™ for Observability Platforms and Positioned Furthest in Completeness of Vision15.7.2026 20:21:00 CEST | Press release
Named a Leader for the third consecutive year and placed furthest in vision for the second year in a row, the company has had a landmark year of innovation as observability becomes essential infrastructure for teams building and running AI at scale. Grafana Labs, the company behind the open observability cloud, today announced it has been named a Leader in the Gartner® Magic Quadrant™ for Observability Platforms for the third consecutive year, and positioned furthest on the Completeness of Vision axis for the second year running. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260715814984/en/ 2026 Gartner® Magic Quadrant™ for Observability Platforms We believe this placement reflects where the market is headed: toward open, composable observability that helps teams in the AI era understand systems that are increasingly complex and agentic, and rapidly scaling thanks to AI-assisted engineering. A Platform Built for the AI Era
Spectro Cloud Raises $100 Million Series D to Help Customers Move AI Infrastructure Into Production Across Enterprise, Public Sector, Neocloud and Sovereign Cloud Environments15.7.2026 18:20:00 CEST | Press release
Growth Equity at Goldman Sachs Alternatives leads oversubscribed round with strategic participation from AMD Ventures, Ericsson, LG Technology Ventures, and Maximus as organizations look to turn AI silicon into business outcomes Spectro Cloud, a leading provider of AI infrastructure management software, today announced it has raised more than $100 million in an oversubscribed Series D funding round led by Growth Equity at Goldman Sachs Alternatives, with strategic participation from AMD Ventures, Ericsson, LG Technology Ventures, and Maximus. The new funding brings Spectro Cloud’s total capital raised to $260 million and will accelerate the company’s mission to help enterprises, public sector organizations, neoclouds and sovereign clouds build and operate production AI infrastructure with greater control over cost, security and governance. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260715551858/en/ Spectro Cloud raises $
K-Beauty Goes Global: Sales Surge 53% as Korean Innovation Reshapes Beauty Growth15.7.2026 16:00:00 CEST | Press release
New NIQ data shows K-Beauty value sales rose 53% year-over-year and 131% over two years, underscoring how regional beauty trends, social commerce and ingredient-led innovation are reshaping global beauty growth. NIQ (NYSE: NIQ), a global leader in consumer intelligence, today released new findings showing K-Beauty has become a rapidly growing global beauty segment, with value sales up 53% year-over-year and 131% over the past two years. The data points to a broader shift in beauty growth, as regional innovation, social commerce and digitally driven consumer demand increasingly shape what scales globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260715867578/en/ K-Beauty accelerates across global markets In its latest report, K-Beauty Goes Global, NIQ shows how Korean beauty is reshaping consumer expectations, accelerating innovation cycles and redefining competitive dynamics across the global beauty market. What began
Viz.ai to Support the MINUTE Trial, a Landmark Multicenter Study Evaluating the SCUBA Technique for the Treatment of Intracerebral Hemorrhage15.7.2026 15:00:00 CEST | Press release
Viz Neuro™ Suite, including Viz ICH™ and Viz ICH Plus™, to facilitate rapid detection and care coordination for patients with basal ganglia hemorrhage across trial sites nationwide. Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced its support for the Minimally Invasive Neurosurgery Trial for Ultra-early Treatment (MINUTE) Trial, a prospective, multicenter, randomized study evaluating whether the SCUBA technique, an endoscopic, catheter-based approach for ultra-early evacuation of basal ganglia intracerebral hemorrhage (BGH), is a promising alternative to standard medical management to potentially improve functional patient outcomes. The study aims to initiate both randomization and surgical intervention within 120 minutes of key clinical time points, reflecting the urgent nature of intracerebral hemorrhage care. Participating sites will have the ability to leverage the Viz Neuro Suite platform, including Viz ICH and Viz ICH Plus, to
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