Myovant seeks EMA approval in uterine fibroids

10 March 2020

Basel, Switzerland-based Myovant Sciences (NYSE: MYOV), a company focused on women's health and prostate cancer that is now majority-owned by Japanese drug major Sumitomo Dainippon Pharma (TYO: 4506), is closing in on a major market with its lead product.

The company has announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relugolix combination tablet (relugolix/estradiol/norethindrone acetate) for the treatment of women with moderate to severe symptoms associated with uterine fibroids.

Myovant, which is planning a US filing for next month, expects the EMA to perform a technical validation of the MAA this month to ensure all essential regulatory elements required for scientific assessment are included in the application prior to the start of the procedure.

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