Myovant’s, Pfizer's Relugolix Shows Promise in Late-Stage Uterine Fibroid Trial
Myovant Sciences and Pfizer have announced that their once-daily relugolix combination therapy significantly improved symptoms for women with uterine fibroids in a phase 3 trial.
In the study enrolling 229 women, 78.4 percent of participants taking the relugolix combination therapy (relugolix/estradiol/norethindrone acetate) achieved a sustained response through week 76, defined as menstrual bleeding of less than 80 milliliters.
In addition, 69.8 percent of women who continued taking the treatment remained responsive through week 104, while 88.3 percent of women who stopped treatment suffered heavy menstrual bleeding after discontinuation, the drugmakers said.
The FDA has set June 1 as its target decision date for agency approval of the combination therapy.