Myovant Sciences files NDA for once-daily relugolix for advanced prostate cancer

Switzerland-based Myovant Sciences (NYSE: MYOV) shares were up 8.8% at $12.60 pre-market, after it revealed it has submitted a New Drug Application (NDA) to the US Food and Drug Administration for once-daily, oral relugolix (120mg) for the treatment of men with advanced prostate cancer.

Myovant, now majority-owned by Japanese drug major Sumitomo Dainippon Pharma (TYO: 4506), also announced that it expects to submit its NDA for once-daily, oral relugolix combination tablet (relugolix 40mg, estradiol 1.0mg, and norethindrone acetate 0.5mg) for women with heavy menstrual bleeding associated with uterine fibroids in May 2020.

“The submission of our NDA for prostate cancer is a major step towards providing a one pill, once a day potential new treatment option for men with advanced prostate cancer,” said Dr Lynn Seely, chief executive of Myovant Sciences, adding: “Based on the robust efficacy and safety data from the Phase III HERO study, we believe relugolix, if approved, could provide men an important oral alternative to leuprolide injections, the current standard of care.”