OBSV - ObsEva's linzagolix shows sustained efficacy and continued safety in treatment of uterine fibroids

ObsEva (OBSV) announces topline 52-week PRIMROSE 1 and 76-week PRIMROSE 2 results of Yselty (linzagolix), in development for the treatment of women with heavy menstrual bleeding due to uterine fibroids. The Week 52 PRIMROSE 1 results showed that continued treatment with Yselty led to sustained efficacy for the primary endpoint of reduced heavy menstrual bleeding (defined as menstrual blood loss of at least 50% less than baseline and at or below 80 mL).This was seen across all doses of Yselty and was in line with the earlier findings in PRIMROSE 2.The pooled Week 52 results from the two studies showed that at Week 52, 56.4% of women on 100 mg of Yselty met the primary endpoint, and with the higher dose of 200 mg+add-back therapy ((ABT)) the responder rate was 89.3%. In women initially treated with 200 mg without ABT, uterine and fibroid volume reduction is substantially more marked than with

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ObsEva's linzagolix shows sustained efficacy and continued safety in treatment of uterine fibroids