Elagolix: First International Approval.
Medication. 2018 Sep 08;:
Authors: Lamb YN
Elagolix (ORILISSA™), an orally bioavailable, second-generation, non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist, is being developed AbbVie and Neurocrine Biosciences for the remedy of reproductive hormone-dependent issues in girls. In July 2018, the US FDA accepted elagolix tablets for the administration of reasonable to extreme ache related to endometriosis. This approval was based mostly on optimistic leads to two replicate part III trials; further part III trials within the USA, Canada and Puerto Rico are at present evaluating elagolix as each monotherapy and together with low-dose hormone add-back remedy in the identical indication. Elagolix with and with out low-dose hormone add-back remedy can be present process part III scientific improvement for heavy menstrual bleeding related to uterine fibroids within the aforementioned places. This text summarizes the milestones within the improvement of elagolix resulting in its first approval for the administration of reasonable to extreme ache related to endometriosis.
PMID: 30194661 [PubMed – as supplied by publisher]