FDAnews
www.fdanews.com/articles/201066-myovant-sciences-pfizers-endometriosis-therapy-shows-efficacy-in-phase-3-study
pfizerlogo.gif

Myovant Sciences’, Pfizer’s Endometriosis Therapy Shows Efficacy in Phase 3 Study

January 28, 2021

Pfizer’s and Myovant Sciences’ investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1 mg and norethindrone acetate 0.5 mg) helped reduce menstrual pain and nonmenstrual pelvic pain in women with endometriosis, according to findings from a phase 3 trial.

Data from the study found that 84.8 percent of participants given the combination treatment over one year experienced clinically meaningful reductions in menstrual pain, while 73.3 percent saw meaningful reductions in nonmenstrual pelvic pain.

The companies said that they will include the phase 3 data in a New Drug Application (NDA) for the combination treatment, which they expect to submit in the first half of the year.

View today's stories