Yselty (linzagolix) demonstrates positive results in two Phase III trials for Uterine Fibroids
Linzagolix, a novel, once-a-day, oral GnRH receptor antagonist was reported to significantly decrease menstrual blood loss vs. placebo at 52 weeks; responder rates for women receiving 200 mg with ‘Add Back Therapy’ (1 mg estradiol and 0.5 mg norethindrone daily) were 91.6 %.
Source:
Biospace Inc.
SPS commentary:
The company states it is planning regulatory submissions to the U.S. FDA in the first half of 2021 and to the European medicines Agency in the fourth quarter of 2020.