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- Title
Elagolix: First Global Approval.
- Authors
Lamb, Yvette N.
- 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.
- Subjects
LUTEINIZING hormone releasing hormone antagonists; ENDOMETRIOSIS; PAIN management; DRUG approval; SEVERITY of illness index
- Publication
Drugs, 2018, Vol 78, Issue 14, p1501
- ISSN
0012-6667
- Publication type
Article
- DOI
10.1007/s40265-018-0977-4