The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval for ObsEva SA's (NASDAQ:OBSV) linzagolix, an oral GnRH antagonist to manage moderate to severe symptoms of uterine fibroids.
- If approved, linzagolix would be the first and only approved GnRH receptor antagonist with a non-hormonal option to address the needs of women who cannot or do not want to take hormones.
- The positive opinion adopted is based on 52-week treatment results from the two Phase 3 PRIMROSE trials and supportive results from both trials' 76-week post-treatment follow-up periods.
- Both studies evaluated full suppression (200 mg once daily) and partial suppression (100 mg once daily) doses of linzagolix, with and without hormonal add-back therapy (ABT).
- Both the trials met their primary endpoints, with all doses showing statistically significant and clinically relevant reductions in heavy menstrual bleeding (HMB) compared to placebo.
- The linzagolix application is also under FDA review for uterine fibroids, with a PDUFA date of September 13, 2022.
- Price Action: OBSV shares are up 4.11% at $2.28 during the market session on the last check Friday.
