- Myovant Sciences submits New Drug Application (NDA) to the FDA for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer. - Myovant announces positive results from Phase 3 SPIRIT 2 study evaluating once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis and from a separate ovulation inhibition study. - Myovant expects to submit an NDA for once-daily rel
LONDON and NEW YORK, April 24, 2020 /PRNewswire/ -- Sumitovant Biopharma Ltd. today announced that Myovant Sciences, one of five healthcare companies in the Sumitovant family of companies, achieved multiple milestones with its relugolix therapies for the treatment of advanced prostate cancer and endometriosis. Myovant, a healthcare company focused on redefining care for women’s health and prostate cancer, announced on April 21, 2020 its submission of a New Drug Application(NDA) to the U.S. Food and Drug Administration (FDA) for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer. The NDA submission is supported by the positive results from the Phase 3 HERO study with a 96.7% response rate in men with advanced prostate cancer. The randomized pivotal study compared relugolix versus leuprolide acetate and also demonstrated superiority to leuprolide acetate on six key secondary endpoints. If approved, relugolix could provide men with an important oral alternative to leuprolide injections, the current standard of care. In addition, on April 22, 2020 Myovant announced positive results from SPIRIT 2, the first of two Phase 3 studies evaluating once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis and from a separate ovulation inhibition study. SPIRIT 2 met both co-primary endpoints with 75.2% of women achieving a clinically-meaningful reduction in dysmenorrhea (menstrual pain) versus 30.4% of women in the placebo group (p<0.0001), and a 66.0% response rate versus 42.6% response rate in the placebo group (p<0.0001) for non-menstrual pelvic pain. Six key secondary endpoints were also met. Women receiving once-daily relugolix combination therapy, on average, had a 75.1% reduction on the Numerical Rating Scale for dysmenorrhea from 7.2 (severe pain) to 1.7 (mild pain). Relugolix combination therapy was generally well-tolerated and bone mineral density changes were minimal. In a separate ovulation inhibition study, relugolix combination therapy demonstrated 100% ovulation inhibition and 100% return of ovulation or menses upon discontinuation of treatment. Myovant expects to submit another NDA for once-daily relugolix combination tablet for women with uterine fibroids in May 2020. “We are pleased with Myovant’s progress developing once-daily, oral relugolix monotherapy and relugolix combination therapy,” said Myrtle Potter, CEO of Sumitovant Biopharma, a wholly-owned subsidiary of Sumitomo Dainippon Pharma. “Myovant’s mission to redefine care for women’s health and prostate cancer aligns with Sumitovant’s goal to make a difference in the lives of people globally by rapidly developing innovative medicines with our technology-enabled approach to drug development and commercialization. In doing so we believe we have the potential to become a core growth engine for our parent company, Sumitomo Dainippon Pharma.” About Sumitovant Biopharma Ltd. About Sumitomo Dainippon Pharma Co., Ltd. About Myovant Sciences Forward-Looking Statements For more information with respect to Myovant Sciences, including disclosure regarding the risks and uncertainties related to any forward-looking statements, please refer to Myovant Sciences’ filings with the United States Securities and Exchange Commission (“SEC”), including under the heading “Risk Factors” in Myovant Sciences’ Quarterly Report on Form 10-Q filed on February 10, 2020, as such risk factors may be amended, supplemented or superseded from time to time. Sumitovant Media Contact: Myovant Media Contact: Myovant Investor Contact:
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