EU approves Yselty for endometriosis treatment

This approval, effective immediately, applies to EU markets (excluding the UK and non-EU markets).

Theramex in-licensed Linzagolix from Kissei Pharmaceutical Co., Ltd. in 2022, and this achievement underscores Theramex’s unwavering commitment to advancing women’s health.

Endometriosis is a chronic and often painful condition that affects millions of women globally, and can significantly impact their quality of life.

The efficacy of linzagolix was evaluated in a Phase III, randomised, double-blind, placebo-controlled study (EDELWEISS 3) involving 484 women aged 18–49 with moderate to severe endometriosis-associated pain, treated for up to six months. The daily dose of 200 mg linzagolix with add-back therapy (ABT) met the primary efficacy objectives, demonstrating clinically meaningful and statistically significant reductions in dysmenorrhea and non-menstrual pelvic pain at three months, with stable or reduced use of analgesics. At three months, 73% of participants in the 200 mg linzagolix with ABT group responded to treatment for dysmenorrhea (P < 0.001 versus placebo) and 47% showed a response for non-menstrual pelvic pain (P = 0.007 versus placebo) – compared with rates of 24% and 31% of participants in the placebo group respectively. The most frequent adverse event reported was headache, occurring at similar rates in both the linzagolix 200 mg with ABT and placebo groups (10.5% versus 8.0%, respectively). Hot flashes and fatigue were reported more frequently in the linzagolix 200 mg with ABT group compared to the placebo group (6.8% each for linzagolix versus 2.5% each for placebo).