Elagolix: First Global Approval

Yvette N Lamb
Drugs · 2018 · vol. 78(14) , pp. 1501–1508 · doi:10.1007/s40265-018-0977-4 · PMID:30194661 · W2889874928
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Elagolix, a novel oral GnRH antagonist, received FDA approval for treating endometriosis-associated pain based on positive phase III trial results.

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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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Condition tags

mesh:D004715endometriosis

MeSH descriptors

Hormone Antagonists Hydrocarbons, Fluorinated Pain Pyrimidines Receptors, LHRH Drug Approval Drug Therapy, Combination Endometriosis Endometriosis Female Hormone Antagonists Hormone Antagonists Hormone Antagonists Humans Hydrocarbons, Fluorinated Hydrocarbons, Fluorinated Hydrocarbons, Fluorinated Pain Pain Management Pain Management

Citation neighborhood

Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. [ expand to 2 hops ] — adds papers reached through this work's immediate citers/citees. Heavier; up to 60 extra dots.

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