Takeda Pharmaceutical has announced positive top-line data from a Phase III confirmatory trial of relugolix in the treatment of uterine fibroids.
The trial looked at the efficacy and safety of oral relugolix versus leuprorelin acetate for 24 weeks in Japanese women. Takeda said the trial: “Demonstrated that relugolix was statistically non-inferior to leuprorelin acetate.”
In April 2016 Takeda and Myovant Sciences entered into a co-development deal for the candidate. Takeda said it plans to submit to regulatory authorities in Japan in this indication.
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