Myovant and Takeda's relugolix meets in Phase III for uterine fibroid pain

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and partner Myovant Sciences GmbH (NYSE:MYOV) reported top-line data from the Phase III TAK-385-3008 trial in 65 women with pain associated with uterine fibroids showing that once-daily 40 mg oral relugolix (TAK-385) for 12 weeks met the primary endpoint of a greater proportion of patients who achieved a maximum Numerical Rating Scale (NRS) pain score of ≤1 point during the 28 days before the final dose vs. placebo. (57.6% vs. 3.1%, p<0.0001). Secondary endpoints in the double-blind, Japanese trial include mean NRS score, number of days without pain symptoms and safety.

In October, the partners reported data from the Japanese Phase III TAK-385/CCT-002 trial to treat symptomatic uterine fibroids showing that relugolix met the primary endpoint of non-inferiority to leuprorelin acetate in reducing menstrual bleeding (see BioCentury, Oct. 6)...