ObsEva Presents Linzagolix Data From Uterine Fibroid Trials

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  • ObsEva SA OBSV has announced data from PRIMROSE (1 and 2) Phase 3 study of linzagolix for uterine fibroids.
  • The data were presented at the American Society for Reproductive Medicine (ASRM) 2021 Scientific Congress & Expo.
  • Related: ObsEva Files US Application For Linzagolix For Uterine Fibroids.
  • Once-daily treatment of 200 mg linzagolix without Hormonal Add-Back Therapy (ABT) reduced uterine and fibroid volume by 39% and 49%, respectively, after 24 weeks. 
  • However, co-administration of hormonal ABT after 24 weeks counteracted the uterine volume reducing effects at 52 weeks, corresponding to a 21% reduction.
  • ObsEva also presented final data from the linzagolix study for severe adenomyosis (breaking of the inner lining of the uterus).
  • A high dose of 200 mg linzagolix reduced uterine volume by 55% from baseline at 12 weeks and 32% at 24 weeks after continued treatment with 100 mg linzagolix. 
  • Pelvic pain was markedly reduced at 12 and 24 weeks, with initial reduction signs after four weeks. 
  • Overall, significant improvements in quality of life were reported.
  • Price Action: OBSV shares traded higher by 0.73% at $2.76 premarket on the last check Wednesday.
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