ACOG Develops Consensus on Medical Menstrual Suppression
Guidance emphasizes role of hormonal therapy and should be accompanied by counseling, including discussions of effectiveness of therapy
Guidance emphasizes role of hormonal therapy and should be accompanied by counseling, including discussions of effectiveness of therapy
The approval was based on data from the phase 3 SPIRIT program, which included the SPIRIT 1 and 2 studies, as well as the first 28 weeks of an open-label extension study.
The study enrolled women who completed the 24-week LIBERTY 1 and 2 studies and the 28-week open-label extension studies, and who met the definition of a responder.
Interview with Andrea Lukes, MD, MHSc, FACOG, board certified obstetrician/gynecologist and found and CEO of the Carolina Women’s Research and Wellness Center.
The FDA extended the action date to review additional information regarding bone mineral density.
Linzagolix is a novel, oral gonadotropin-releasing hormone (GnRH) receptor antagonist.
The NDA submission is supported by data from the phase 3 PRIMROSE 1 and PRIMROSE 2 studies, along with data from the 76-week post-treatment follow-up study.
The application is supported by data from the phase 3 SPIRIT program, which includes the SPIRIT 1 and SPIRIT 2 studies, as well as an open-label extension study.
Myfembree consists of relugolix, a gonadotropin-releasing hormone receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin.
Myfembree is a combination of relugolix, a gonadotropin-releasing hormone receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin.