Research & Development
Theramex Gains European Commission Marketing Authorization for Yselty, an Oral GnRH Antagonist, for the Treatment of Symptoms of Uterine Fibroids
21 June 2022 - - The European Commission has granted Marketing Authorization for Yselty (linzagolix), an oral GnRH antagonist, indicated for the treatment of moderate to severe symptoms of Uterine Fibroids in adult women (over 18 years of age) of reproductive age, UK-based speciality pharmaceutical company Theramex said.

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 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.

The approval is based on positive data from the ObsEva's two Phase 3 PRIMROSE trials.

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 US, Canada, and Asia.

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.

Theramex is a 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.

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.

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 and 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.


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