#127330
Re: Farmas USA
MYOV, PFE
Anucio de publicación fase III Liberty en el New England Journal of Medicine. Info conocida
Anucio de publicación fase III Liberty en el New England Journal of Medicine. Info conocida
- LIBERTY 1 and LIBERTY 2 achieved 73.4% and 71.2% response rates in menstrual blood loss, with an average reduction of 84.3% from baseline
- Achieved six of seven key secondary endpoints including reduction of pain
- Bone mineral density maintained at levels comparable to placebo
- Data were included in U.S. New Drug Application for relugolix combination tablet for uterine fibroids
BASEL, Switzerland and NEW YORK, Feb. 17, 2021 (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 < 0.001). 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 an 84.3% reduction in menstrual blood loss from baseline in each study (both p < 0.001 compared to placebo).
“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 < 0.001 compared to placebo), and improvement in anemia in those women with anemia at baseline (both p < 0.05 compared to placebo). In addition, among the approximately 50% of women with moderate-to-severe pain at baseline, a significantly greater proportion of women receiving relugolix combination therapy reported minimal-to-no pain (maximum score of 1 on a 0 to 10 Numerical Rating Scale) during the last 35 days of treatment compared to placebo (43% vs. 10% and 47% vs. 17%, respectively; both p < 0.001). A seventh key secondary endpoint for reduction in fibroid volume was not achieved in either study.
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 for relugolix combination tablet for uterine fibroids, with an 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.
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