Roivant subsidiary Myovant Sciences announced positive topline results from its Phase 3 LIBERTY 1 trial of relugolix combination therapy in women with uterine fibroids. An estimated 5 million women in the U.S. suffer from symptoms of uterine fibroids. Myovant expects topline data from a replicate Phase 3 study, LIBERTY 2, in the third quarter of 2019. If successful, Myovant plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2019.
"I would like to congratulate the Myovant team on these positive Phase 3 results from LIBERTY 1. We're incredibly proud of the team's efforts to improve the lives of women with limited options today," said Dr. Mayukh Sukhatme, President of Roivant Pharma. "These results come within several months of other positive clinical data readouts elsewhere in the Roivant family. We look forward to six additional Phase 3 readouts as well as numerous earlier-stage clinical results across the Roivant family over the next 18 months."
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