(GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced publication in the New England Journal of Medicine of the Phase 3 LIBERTY 1 and LIBERTY 2 studies of investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids. As previously reported, both studies achieved the primary endpoint of response rates in menstrual blood loss in addition to six of the seven key secondary endpoints, while maintaining bone mineral density comparable to placebo as part of a well-tolerated safety profile over 24 weeks.
"Women with uterine fibroids often suffer from symptoms such as heavy menstrual bleeding and pain, which can significantly impact their quality of life over many years," said Ayman Al-Hendy, M.D., Ph.D., Professor of Obstetrics and Gynecology, University of Chicago, and lead author of the publication. "In the LIBERTY studies, relugolix combination therapy improved the most bothersome symptoms of uterine fibroids and had a well-tolerated safety profile including maintenance of bone mineral density comparable to placebo. The data published in the New England Journal of Medicine underscore the potential of relugolix combination therapy to provide an important new treatment option for this common disease."
LIBERTY 1 and LIBERTY 2 each met the primary endpoint, with 73.4% and 71.2% of women in the relugolix combination therapy groups achieving the responder criteria compared with 18.9% and 14.7% of women in the placebo groups at Week 24, respectively (both p
"We are pleased that the New England Journal of Medicine recognized the importance of our Phase 3 LIBERTY program and published the study results, which support the potential of once-daily relugolix combination therapy in women with uterine fibroids," said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. "As we approach our FDA target action date of June 1, we look forward, if approved, to providing a one pill, once-a-day treatment for the millions of women with uterine fibroids who need and deserve new options."
In LIBERTY 1 and LIBERTY 2, six of seven key secondary endpoints measured at Week 24 achieved statistical significance, including mean reduction in menstrual blood loss, amenorrhea, reduction in pain in women with pain at baseline, improvement on the Bleeding and Pelvic Discomfort scale, reduction in uterine volume (all p
Data showed changes in bone mineral density were comparable between the relugolix combination and placebo groups at the end of treatment in LIBERTY 1 and LIBERTY 2. The overall incidence of adverse events in the relugolix combination and placebo groups were also comparable (62% vs. 66% and 60% vs. 59%, respectively), including hot flashes (11% vs. 8% and 6% vs. 4%, respectively). There were no pregnancies reported in the relugolix combination groups in either study.
"The heavy bleeding and pain that women with uterine fibroids commonly experience can have a significant impact on their everyday lives," said James Rusnak, M.D., Ph.D., Senior Vice President, Chief Development Officer, Internal Medicine and Hospital, Global Product Development at Pfizer. "These data offer strong evidence that relugolix combination therapy, if approved, could be an important new oral treatment with the potential to help patients living with this debilitating condition."
Data from LIBERTY 1 and LIBERTY 2, in addition to the 28-week long-term extension study, were included in the New Drug Application (NDA) for relugolix combination tablet for uterine fibroids, with the FDA decision expected by the June 1, 2021 target action date. Myovant previously announced results from the LIBERTY long-term extension study in February 2020. At one year, 87.7% of women receiving relugolix combination therapy met the responder criteria. In addition, women experienced, on average, an 89.9% reduction in menstrual blood loss from baseline at one year. Changes in bone mineral density and the incidence of adverse events were consistent with those in LIBERTY 1 and LIBERTY 2.
About Uterine Fibroids
Uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus and are among the most common reproductive tract tumors in women. In addition to an individual's genetic predisposition, estrogens are well known to play an important role in the regulation of fibroid growth.
Although uterine fibroids are benign tumors, they can cause debilitating symptoms such as heavy menstrual bleeding (frequently resulting in anemia and fatigue), pain (including painful periods, abdominal pain, painful intercourse, backache), increased abdominal girth and bloating, urinary frequency or retention, constipation, pregnancy loss, and, in some cases, infertility. These symptoms can also lead to loss of productivity at work, limitations in normal activities of daily living, and social embarrassment.
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
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We have one FDA-approved medicine, ORGOVYXTM
