First in the world: Innovative treatment for uterine fibroids approved by EU

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First in the world: Innovative treatment for uterine fibroids approved by EU

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First in the world: Innovative treatment for uterine fibroids approved by EU. 

On June 18, ObsEva and Theramex jointly announced that the European Commission (EC) granted marketing authorization for the oral gonadotropin-releasing hormone (GnRH) antagonist Yselty (linzagolix).

According to the press release, Yselty will be the first in the EU to treat adult female patients of reproductive age with moderate to severe uterine fibroids with or without concomitant hormonal add-back therapy ( >18 years) medicines.

Uterine fibroids are a common benign uterine muscle tissue tumor that occurs in about 25% of women of reproductive age.

Fibroids vary in size and can cause symptoms of varying degrees, such as heavy bleeding during menstruation, anemia, flatulence, frequent urination, pain, etc., which seriously affect the quality of life.

Sometimes it even causes anxiety, pain and psychological problems. Many patients with severe symptoms even require surgery.

Yselty is an oral, once-daily GnRH antagonist. Yselty was developed to give patients flexibility when choosing a dose.

Regardless of whether patients with uterine fibroids themselves received endocrine reverse add-on therapy.

Yselty offers a potential “best-in-class” efficacy and tolerability for women receiving endocrine reverse add-on therapy.

For those patients who are unable or unwilling to receive endocrine reverse add-on therapy, this drug is the first oral GnRH antagonist in the EU that can be used without endocrine reverse add-on therapy. The U.S. FDA is currently reviewing a New Drug Application (NDA) for linzagolix.

▲ Molecular formula of Linzagolix (Image source: Ed (Edgar181), Public domain, via Wikimedia Commons)

The marketing approval for Yselty is based on positive results from two PRIMROSE Phase 3 studies.

Combination trial data at week 24 showed efficacy in 84.5% of women who received 200 mg of Yselty and concurrent endocrine reverse add-on therapy.

Among those women who received 100 mg of Yselty without concomitant endocrine reverse add-on therapy, 56.5 percent achieved remission.

“As the first GnRH antagonist that can be used with or without concurrent endocrine reverse add-on therapy, Yselty has the potential to transform the treatment of women with uterine fibroids,” said Dr. Brandi Howard, Chief Clinical Medical Officer of ObsEva. “We are delighted that Yselty is the first alternative option for physicians and the millions of women who are unable or unable to receive endocrine reverse add-on therapy.”

References:

[1] ObsEva Announces European Commission Marketing Authorization for Yselty® (linzagolix), an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids. Retrieved June 17, 2022 from https://www.obseva.com/pressrelease-detail/?pr =5038

[2] Theramex Announces European Commission Marketing Authorization for Yselty® (linzagolix), an Oral GnRH Antagonist, for the treatment of symptoms of Uterine Fibroids. Retrieved June 17, 2022 from https://www.theramex.com/news/theramex- announces-european-commission-marketing-authorization-for-yselty-linzagolix-an-oral-gnrh-antagonist-for-the-treatment-of-symptoms-of-uterine-fibroids/

First in the world: Innovative treatment for uterine fibroids approved by EU

(source:internet, reference only)

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