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Sumitovant Biopharma Announces Priority Review and FDA Acceptance of Myovant Sciences NDA for Once-Daily, Oral Relugolix for Advanced Prostate Cancer

Sumitovant Biopharma is pleased to announce that the U.S. Food and Drug Administration(FDA) has accepted for Priority Review, the New Drug Application (NDA) submitted by Myovant Sciences (NYSE: MYOV), for once-daily, oral relugolix (120 mg) for the treatment o

Benzinga · -
Sumitovant Biopharma is pleased to announce that the U.S. Food and Drug Administration(FDA) has accepted for Priority Review, the New Drug Application (NDA) submitted by Myovant Sciences (NYSE: MYOV), for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer. Myovant, a member of the Sumitovant family of companies, is a healthcare company focused on redefining care for women and for men. "We are delighted that the FDA has accepted for Priority Review our New Drug Application for relugolix, bringing us one step closer to providing a one pill, once-a-day potential new treatment option to men with advanced prostate cancer," said Lynn Seely, M.D., chief executive officer of Myovant Sciences."As recently published in the New England Journal of Medicine, relugolix demonstrated superior efficacy and a 54% lower risk of major adverse cardiovascular events compared to the current standard of care, leuprolide acetate injections, in the Phase 3 HERO study." "The FDA's Priority Review designation as well as our peer-reviewed Relugolix data validates the importance of Sumitovant's and its family of companies novel approach to drug development of therapies with the potential to address critical unmet needs," said Sam Azoulay, chief medical officer of Sumitovant Biopharma. The FDA grants Priority Review to applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The FDA has set a target action date of December 20, 2020 under the Prescription Drug User Fee Act (PDUFA). In its acceptance letter, the FDA also stated that it is currently not planning to hold an advisory committee meeting for this application. If approved, relugolix would be the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist treatment for men with advanced prostate cancer. In May 2020, Myovant submitted a separate NDA for once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women with heavy menstrual bleeding associated with uterine fibroids. A Marketing Authorization Application for relugolix combination tablet in women with moderate to severe symptoms associated with uterine fibroids is also under review by the European Medicines Agency.