FDA to Review Data on Long-Term Use of Myfembree for Uterine Fibroids
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.
Menorrhagia
Linzagolix Under Review for Treatment of Uterine Fibroids
Linzagolix is a novel, oral gonadotropin-releasing hormone (GnRH) receptor antagonist.
Linzagolix NDA Submitted for Uterine Fibroid Treatment
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.
Dexamethasone Studied for Treatment of Heavy Menstrual Bleeding
Results of dose-finding study suggest dexamethasone is safe for use at a dosage of 1.8 mg daily for five days per menstrual cycle
Myfembree Now Available for Heavy Menstrual Bleeding With Uterine Fibroids
Myfembree consists of relugolix, a gonadotropin-releasing hormone receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin.
Myfembree Approved for Heavy Menstrual Bleeding With Uterine Fibroids
Myfembree is a combination of relugolix, a gonadotropin-releasing hormone receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin.
Consistent Benefits Seen With Linzagolix in Uterine Fibroids Trial
At 76 weeks, results showed that off-treatment pain scores remained lower than baseline across all linzagolix treatment arms.
Relugolix Combo Therapy Beneficial for Fibroid-Related Menorrhagia
Significantly more women had reduced menstrual bleeding with once-daily relugolix combination therapy versus placebo
FDA to Review Relugolix Combination Therapy for Uterine Fibroids
The NDA submission is supported by results from the phase 3 LIBERTY program.
Sustained Clinical Benefits Observed With Linzagolix in Uterine Fibroid Trials
Positive topline data were announced from two phase 3 studies evaluating the efficacy and safety of linzagolix (Yselty®; ObsEva) for the treatment of heavy menstrual bleeding due to uterine fibroids.
