Myovant Sciences, part of a constellation of biotech startups, said Tuesday that its treatment for uterine fibroids succeeded in the first of two large trials, a major step toward winning approval.
The drug, relugolix, met its goal of significantly reducing menstrual blood loss over 24 weeks and beat placebo on six other metrics including pain and quality of life. In the roughly 400-patient trial, relugolix was similar to placebo, including on the key measure of bone density.
A second, nearly identical study of relugolix is expected to read out in the coming months. If it too is a success, Myovant expects to file for Food and Drug Administration approval later this year.