Obseva NDA for Uterine Fibroids Accepted for Review

FDA has accepted for review an Obseva NDA for linzagolix for managing heavy menstrual bleeding associated with uterine fibroids in premenopausal women. Linzagolix is described as an GnRH receptor antagonist with flexible dosing options for uterine fibroids, including a low dose option to address the needs of women who cannot or do not want to take hormones. The agency set a user fee review action target date of 9/13/2022.

The submission is based on data from two Phase 3 PRIMROSE trials that investigated the efficacy and safety of two dosing regimens, 100mg once daily and 200mg once daily, alone or in combination with hormonal add-back therapy (1 mg estradiol and 0.5 mg norethisterone acetate). It includes 24-week treatment results from both studies, as well as supportive results from Week 52 and the 76-week post-treatment follow-up, Obseva says.