Posted by Michael Wonder on 21 Apr 2020
Myovant Sciences Submits new drug application to the FDA for once daily, oral relugolix for the treatment of men with advanced prostate cancer
21 April 2020 - Myovant expects to submit a second application for relugolix combination tablet for women with uterine fibroids in May 2020.
Myovant Sciences today announced that it has submitted a new drug application to the U.S. FDA for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer.
The submission is supported by positive results from the Phase 3 HERO study, a randomised pivotal study comparing relugolix versus leuprolide acetate.
