Myovant Sciences, Pfizer: Positive Trial Data Of Relugolix Combination Therapy In Endometriosis

Myovant Sciences (MYOV) and Pfizer Inc. (PFE) announced Tuesday positive one-year data from phase 3 SPIRIT extension study of once-daily Relugolix combination therapy in women with endometriosis.

In Pre-market activity on the NYSE, Myovant Sciences shares were trading at $22, up 6.23 percent.

The Phase 3 SPIRIT long-term extension study of the investigational once-daily relugolix combination therapy includes relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg. The trial data reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain over one year with minimal and stable bone mineral density loss.

In the SPIRIT long-term extension study, 84.8% and 73.3% of women receiving relugolix combination therapy over one year achieved clinically meaningful pain reductions in dysmenorrhea and non-menstrual pelvic pain, respectively.

The data are consistent with the efficacy and safety profile observed through 24 weeks in the Phase 3 SPIRIT 1 and SPIRIT 2 studies.

These results will be included in the New Drug Application to the U.S. Food and Drug Administration for relugolix combination tablet for the treatment of women with endometriosis, anticipated to be submitted in the first half of 2021.

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