Positive results from second phase III study of once-daily relugolix combination therapy in women with uterine fibroids and positive bioequivalence study

Myovant Sciences announced that LIBERTY 2, the second of two Phase III studies of once-daily relugolix combination therapy, met its primary efficacy endpoint and six key secondary endpoints in women with uterine fibroids. In addition, relugolix combination therapy maintained bone mineral density at levels comparable to placebo over 24 weeks and was generally well- tolerated. These results confirm the previously announced data from the Phase III LIBERTY 1 study and enable an NDA submission to the FDA by the end of this year.

Myovant Sciences also announced that a separate clinical study of single-tablet relugolix combination therapy met all required and pre-specified FDA criteria for bioequivalence , providing critical data necessary to include the once-daily, single-tablet regimen in the NDA submission for approval of the treatment for uterine fibroids. The single-tablet regimen is the formulation intended to be offered to women should relugolix combination therapy receive FDA approval. In the primary endpoint analysis of LIBERTY 2, 71.2% of women receiving once-daily relugolix combination therapy achieved the responder criteria compared with 14.7% of women receiving placebo (p < 0.0001). A response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method. On average, women receiving relugolix combination therapy experienced a highly significant 84.3% reduction in menstrual blood loss from baseline (p < 0.0001). In addition, a significantly greater proportion of women suffering from moderate-to-severe pain from uterine fibroids at baseline experienced no pain or minimal pain during the last 35 days of treatment with relugolix combination therapy compared with women on placebo (p < 0.0001).