PFE Pfizer Inc

By Chris Wack

Myovant Sciences and Pfizer Inc. reported positive results from a Phase 3 long-term extension study of the investigational once-daily relugolix combination.

The companies said the therapy in women with endometriosis showed clinically meaningful reductions in dysmenorrhea and nonmenstrual pelvic pain over one year with minimal and stable bone mineral density loss. The data were consistent with the efficacy and safety profile observed through 24 weeks in the previous Phase 3 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, which the companies intend to submit in the first half of 2021, they said.

In the 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 nonmenstrual pelvic pain, respectively. Bone mineral density remained stable through Week 52 in women treated with relugolix combination therapy after minimal, nonclinically meaningful bone loss through Week 24, the companies said.

In December, Myovant and Pfizer entered into a collaboration for the development and commercialization of relugolix in oncology and women's health in the U.S. and Canada. Myovant and Pfizer will jointly develop and commercialize Orgovyx relugolix in advanced prostate cancer and, if approved, relugolix combination tablet in uterine fibroids and endometriosis, they said.

Myovant shares were up 6% to $22 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

January 26, 2021 08:12 ET (13:12 GMT)

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