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Review
. 2018 Sep;78(14):1501-1508.
doi: 10.1007/s40265-018-0977-4.

Elagolix: First Global Approval

Yvette N Lamb  1
Affiliations
Review

Elagolix: First Global Approval

Yvette N Lamb. Drugs. 2018 Sep.

Erratum in

Abstract

Elagolix (ORILISSA™), an orally bioavailable, second-generation, non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist, is being developed AbbVie and Neurocrine Biosciences for the treatment of reproductive hormone-dependent disorders in women. In July 2018, the US FDA approved elagolix tablets for the management of moderate to severe pain associated with endometriosis. This approval was based on positive results in two replicate phase III trials; additional phase III trials in the USA, Canada and Puerto Rico are currently evaluating elagolix as both monotherapy and in combination with low-dose hormone add-back therapy in the same indication. Elagolix with and without low-dose hormone add-back therapy is also undergoing phase III clinical development for heavy menstrual bleeding associated with uterine fibroids in the aforementioned locations. This article summarizes the milestones in the development of elagolix leading to its first approval for the management of moderate to severe pain associated with endometriosis.

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Conflict of interest statement

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Yvette Lamb is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Figures

None
Chemical structure of elagolix
See this image and copyright information in PMC

References

    1. AbbVie Inc. Prescribing information for OrilissaTM (elagolix) tablets, for oral use. 2018. http://www.accessdata.fda.gov/. Accessed 15 Aug 2018.
    1. Ng J, Chwalisz K, Carter DC, et al. Dose-dependent suppression of gonadotropins and ovarian hormones by elagolix in healthy premenopausal women. J Clin Endocrinol Metab. 2017;102(5):1683–1691. doi: 10.1210/jc.2016-3845. - DOI - PubMed
    1. Struthers RS, Nicholls AJ, Grundy J, et al. Suppression of gonadotropins and estradiol in premenopausal women by oral administration of the nonpeptide gonadotropin-releasing hormone antagonist elagolix. J Clin Endocrinol Metab. 2009;94(2):545–551. doi: 10.1210/jc.2008-1695. - DOI - PMC - PubMed
    1. AbbVie. AbbVie receives US FDA approval of ORILISSA™ (elagolix) for the management of moderate to severe pain associated with endometriosis. 2018. https://news.abbvie.com/. Accessed 15 Aug 2018.
    1. Abbott. Abbott and Neurocrine announce global agreement to develop and commercialize elagolix for the treatment of endometriosis [media release] 16 Jun 2010. http://www.abbott.com

MeSH terms