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The agency is expected to complete its review by the third quarter of 2027.
Fylrevy is an innovative, orally administered estrogen therapy based on estetrol (E4), designed to treat moderate to severe vasomotor symptoms caused by menopause.
If approved, it would become the first menopausal hormone therapy containing E4 on the U.S. market.
The European Commission granted Fylrevy marketing authorization in March 2026 for all European Economic Area member states. Its approved uses include hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women who have not undergone a hysterectomy and whose last menstrual period was at least 12 months earlier, as well as HRT for estrogen deficiency symptoms in postmenopausal women who have undergone a hysterectomy.
Fylrevy is currently marketed in Hungary, the Czech Republic, Slovakia, Finland and Sweden.
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