Myovant Sciences Presents Additional Data on Bone Mineral Density in Women with Uterine Fibroids from Phase 3 LIBERTY Program and from Prospective Observational Study
BASEL, Switzerland, Sept. 14, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced the presentation of one-year data on bone mineral density (BMD) from the Phase 3 LIBERTY program evaluating the safety and efficacy of once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids. The BMD results from the LIBERTY program demonstrated maintenance of BMD through one year and were consistent with those observed in a separate prospective observational study of untreated, age-matched women with uterine fibroids. The findings were presented at the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting Virtual Event, held September 11-15, 2020.
“Uterine fibroids are a chronic condition, but the duration of use for existing treatment options has been limited by concerns about potential bone loss while on therapy,” said Michael McClung, M.D., founding director of the Oregon Osteoporosis Center. “These new data show relugolix combination therapy maintained bone mineral density over one year of treatment, consistent with that of untreated, age-matched women with uterine fibroids in a concurrent study.”
“We believe these findings add to the unique and growing evidence supporting relugolix combination tablet as a potential long-term treatment option for women with uterine fibroids,” said Juan Camilo Arjona Ferreira, M.D., chief medical officer of Myovant Sciences. “These data further support our vision of providing a one pill, once-a-day treatment that may provide substantial reductions in menstrual blood loss and symptom relief while maintaining bone health.”
Details of the presentations are as follows:
Relugolix Combination Therapy Preserves Bone Mass in Patients with Uterine Fibroids: Results from Phase 3 LIBERTY Program (Abstract # P-641)
Evaluation of Relugolix Combination Therapy to Maintain Bone Mass in Women with Uterine Fibroids Through 52 Weeks: LIBERTY Long-Term Extension Study (Abstract # P-639)
A Prospective Observational Study of Bone Mineral Density in Premenopausal Women with Uterine Fibroids (Abstract # P-552)
Relugolix combination tablet is under review by the U.S. Food and Drug Administration (FDA) for the treatment of women with uterine fibroids, with a target action date of June 1, 2021. Myovant submitted a Marketing Authorization Application to the European Medicines Agency in March 2020 for relugolix combination tablet in uterine fibroids. Additionally, relugolix (120 mg) is under Priority Review by the FDA for the treatment of men with advanced prostate cancer, with a target action date of December 20, 2020. Myovant has also reported positive data from two replicate Phase 3 studies evaluating relugolix combination therapy in women with endometriosis.
About he Phase 3 LIBERTY Program in Uterine Fibroids
LIBERTY 1 and 2 met the primary endpoint (p < 0.0001) with 73.4% and 71.2% of women receiving relugolix combination therapy achieving the responder criteria compared with 18.9% and 14.7% of women receiving placebo at 24 weeks, respectively. On average, women receiving relugolix combination therapy in both studies experienced an 84.3% reduction in menstrual blood loss from baseline (p < 0.0001). Bone mineral density was comparable between the relugolix combination therapy and placebo groups in LIBERTY 1 and 2. The distribution of the change in bone mineral density, including outliers, was similar for the relugolix combination therapy and placebo groups at 24 weeks, as assessed by dual energy x-ray absorptiometry (DXA). The overall incidence of adverse events in the relugolix combination and placebo groups was comparable in both studies.
The open-label extension study also met the primary endpoint with relugolix combination therapy demonstrating an 87.7% response rate at one year, showing the durability of the response observed in LIBERTY 1 and 2. In addition, women experienced, on average, an 89.9% reduction in menstrual blood loss from baseline. Changes in bone mineral density through one year, as assessed by DXA every three months, were consistent with LIBERTY 1 and 2. The incidence of adverse events over one year was consistent with that observed in LIBERTY 1 and 2, with no new safety signals observed.
About Uterine Fibroids
An estimated five million women in the U.S. suffer from symptoms of uterine fibroids, and an estimated three million women are inadequately treated by current medical therapy and require further treatment.
About Myovant Sciences