Women’s health-focused biotech company ObsEva has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for linzagolix for the treatment of uterine fibroids.
Uterine fibroids are common benign tumors of the muscular tissue of the uterus. Uterine fibroids affect women of childbearing age and can vary in size from undetectable to large bulky masses. Few long-term medical treatments are available, and as a result, approximately 300.000 hysterectomies are performed for uterine fibroids every year in the US.
Linzagolix is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile. It is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product. Linzagolix is not currently approved anywhere in the world, which ObsEva is hoping to change now.
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 Brian O’Callaghan, CEO of ObsEva. “Our positive Phase 3 PRIMROSE results underscore linzagolix’s clinical utility and well-known differentiated profile. If approved, linzagolix will be the first oral GnRH antagonist to offer treatment options for women who cannot or do not want to take hormones, as well as for women who are able to take additional hormone therapy. We look forward to overcoming existing challenges in the treatment of uterine fibroids — with linzagolix’s unique low-dose option (100 mg without ABT) and high dose option (200 mg with ABT) — and will work with the FDA through the regulatory process as we prepare for commercialization.”
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.
