Theramex Announces European Commission Marketing Authorization for Yselty® (linzagolix), an Oral GnRH Antagonist, for the Treatment of Symptoms of Uterine Fibroids

Rhea-AI Summary

The European Commission (EC) has granted Marketing Authorization for Yselty® (linzagolix), a novel oral GnRH antagonist for treating moderate to severe symptoms of Uterine Fibroids in women over 18. This decision follows a positive opinion from the Committee for Medicinal Products for Human Use in April 2022. Yselty® offers flexible dosing options with and without hormonal therapy. Approval is based on data from two Phase 3 PRIMROSE trials. ObsEva SA partnered to commercialize Yselty® across international markets.

Positive

• Yselty® is the first oral GnRH antagonist approved in the EU, providing flexible dosing options.
• Approval is based on positive results from two Phase 3 trials, indicating strong clinical efficacy.
• The drug addresses a significant market need, potentially offering relief to 25% of reproductive-age women affected by uterine fibroids.

Negative

• None.

For Media and Investors only

LONDON--(BUSINESS WIRE)-- 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/

For further information, please contact:

Camilla Harder Hartvig

CommunicationsPR@Theramex.com

+44 203 962 5555

Source: Theramex

FAQ

What is Yselty® (linzagolix) approved for?

Yselty® is approved for treating moderate to severe symptoms of Uterine Fibroids in women over 18.

When did the European Commission approve Yselty®?

The European Commission granted Marketing Authorization for Yselty® on [date not specified] following a positive opinion in April 2022.

Who is the partner of ObsEva for Yselty® commercialization?

ObsEva is partnering with Theramex to commercialize Yselty® in international markets outside the U.S., Canada, and Asia.

What are the dosing options for Yselty®?

Yselty® offers flexible dosing options of 100 mg or 200 mg once daily, with or without hormonal therapy.

What clinical trials supported the approval of Yselty®?

The approval of Yselty® was based on data from ObsEva's two Phase 3 PRIMROSE trials.