FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

AbbVie Submits NDA for Uterine Fibroid Drug

Aug. 7, 2019

AbbVie has filed a new drug application for Orilissa (elagolix), a medication for managing heavy menstrual bleeding caused by uterine fibroids.

The application for the oral gonadotropin-releasing hormone (GnRH) antagonist is bolstered by data from a Phase 3 uterine fibroid trial, which evaluated nearly 800 premenopausal women with heavy menstrual bleeding associated with uterine fibroids in two pivotal studies.

Uterine fibroids are non-cancerous tumors found in muscle tissue. While they can be asymptomatic, in some patients they can cause vaginal bleeding, heavy menstrual bleeding and anemia, among other symptoms.

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