GnRH antagonist linzagolix treats uterine fibroids, with positive results in Phase 3 studies

ObsEva SA announced data from the 3rd Phase study (PRIMROSE 1 and 2), which evaluated the effectiveness and safety of the GnRH (gonadotropin-releasing hormone) an tagane Yselty (linzagolix) for the treatment of large period bleeding in patients with uterine fibroidsPRIMROSE 1 reached the primary endpoint at week 24, and the amount of menstrual bleeding was significantly reduced in women receiving linzagolix compared to the placebo (s.80 mL, a decrease of 50% compared to the baseline)New data from PRIMROSE 2 show that 52 weeks of treatment with linzagolix provides consistent efficacy and is well toleratedin two studies, patients treated with linzagolix had statistically significant improvements in many clinically relevant secondary endpoints, including pain reduction, improved anemia, and quality of lifeProfessor Hugh Taylor, of yale, said: "Women with uterine fibroids experience pain and discomfort due to menstrual haemorrhage, and a large number of patients who do not accept or wish to avoid hormone replacement therapy, requiring new and effective treatments that can provide lasting relief to symptoms." These results show that linzagolix can effectively control bleeding, reduce pain associated with fibroids and improve anemiaThis could be a long-awaited new treatment to meet currently unmet needs"
ObsEva is now preparing to submit regulatory documents to the European DrugAdministration(EMA) and the U.SFood and Drug Administration (
FDA), which are expected to be filed in the fourth quarter of 2020 and January 2021, respectivelyData from the entire clinical trial program will be presented to an upcoming scientific conference