ObsEva SA (NASDAQ:OBSV) rose Wednesday after the company reported submission of New Drug Application to the U.S. Food and Drug Administration for linzagolix for the treatment of uterine fibroids.
The Geneva-based company, goes on to say Linzagolix is an oral GnRH receptor antagonist with potential best-in-class efficacy, favorable tolerability profile, and unique and flexible dosing options. Further, if approved, linzagolix will be the only GnRH antagonist in uterine fibroids with a low dose non-add-back therapy (ABT) option.
The NDA submission includes the positive 52-week on treatment results from the Phase 3 PRIMROSE 1 (US only; n=574) and PRIMROSE 2 (Europe and US; n=535) clinical studies as well as supportive results from the 76-week post-treatment follow-up study.
In both studies, patients with heavy menstrual bleeding (HMB) associated with uterine fibroids were administered linzagolix doses of 100 mg or 200 mg, with and without hormonal add-back-therapy (ABT; 1 mg estradiol/0.5 mg norethindrone acetate), or placebo. PRIMROSE 1 and 2 successfully met their primary endpoints, with all doses showing statistically significant and clinically relevant reductions in HMB compared to placebo.
“The NDA submission is a major milestone in making linzagolix available in the U.S., and an important step toward addressing the diverse medical needs that exist for women with uterine fibroids,” said CEO Brian O’Callaghan.
Concurrently, ObsEva is also working closely with the European Medicine Agency’s (EMA) to achieve marketing approval. Linzagolix previously received validation of the marketing authorization application (MAA) with an approval recommendation from the Committee for Medicinal Products for Human Use (CHMP) expected in Q4 2021.
OBSV shares acquired eight cents to $3.09