ObsEva Submits NDA Of Linzagolix To FDA For Treatment Of Uterine Fibroids

(RTTNews) - ObsEva SA (OBSV) said Wednesday that it has submitted a New Drug Application to the U.S. Food and Drug Administration for linzagolix for the treatment of uterine fibroids.

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.

ObsEva said that it is also working closely with the European Medicine Agency's 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 expected in the fourth-quarter 2021.