FDA accepts new drug application for once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for treatment of women with heavy menstrual bleeding associated with uterine fibroids

Submission is based on data from LIBERTY 1 and LIBERTY 2 trials, which met primary endpoint (p<0.0001), with 73.4% and 71.2% of women on the treatment achieving the responder criteria compared with 18.9% and 14.7% of women receiving placebo at 24 weeks, respectively.

SPS commentary:

A marketing application was submitted to the European Medicines Agency for relugolix combination tablet in March 2020 for the treatment of women with moderate to severe symptoms associated with uterine fibroids.


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