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# AbbVie Seeking New Orilissa Indication
- URL: https://www.fdaweb.com/abbvie-seeking-new-orilissa-indication/
- Published: 2020-01-23T12:00:00.000Z
- Updated: 2026-09-14T15:59:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145912

AbbVie says it expects FDA to make a decision before summer on a new indication for its Orilissa (elagolix) to treat uterine fibroids in premenopausal women. The *Philadelphia Inquirer* [reports](https://www.inquirer.com/health/elagolix-fda-apprival-uterine-fibroids-premenopause-20200122.html?ref=fdaweb.com) the agency is considering results from two clinical trials conducted at 77 sites in the U.S. and Canada in which the overwhelming majority of women had blood loss cut by half over six months.

Orilissa was approved by FDA in 2018 to reduce the pain of endometriosis. It reportedly works by suppressing the gonadotropin hormone and the ovarian sex hormones estrogen and progesterone. In effect, the newspaper says, it throws women into temporary menopause.