FDA grants approval of Oriahnn (elagolix, estradiol and norethindrone acetate) capsules, for management of heavy menstrual bleeding associated with uterine leiomyomas in premenopausal women.

Approval was based on two clinical trials (n=591) which demonstrated improvements in the primary endpoint, menstrual blood loss (MBL) <80ml at final month and 50% or greater reduction from baseline vs placebo (Study 1: 68.5% vs 8,7%; Study 2 76.5% vs 10.5%).