Interdisciplinary model-informed drug development for extending duration of elagolix treatment in patients with uterine fibroids.

ABSTRACT:

Aim

Elagolix, a gonadotropin-releasing hormone receptor antagonist, was recently approved for heavy menstrual bleeding associated with uterine fibroids (UF, Oriahnn) at a dose of 300 mg twice daily (BID) in combination with add-back therapy (oestradiol 1 mg/norethindrone acetate 0.5 mg [E2/NETA] once daily) for 24 months use. The limited duration of treatment is related to elagolix dose- and duration-dependent decrease in oestrogen that is mechanistically linked to changes in bone mineral density (BMD). The work herein supported the extended treatment duration of 24 months.

Methods

An integrated exposure-response and epidemiological modelling framework of elagolix effects on femoral neck BMD (FN-BMD), informed by real-world data and phase 3 clinical trials data, was develope

SUBMITTER: Beck D 

PROVIDER: S-EPMC9796281 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature