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The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use has recommended granting a marketing authorization for hormone replacement therapy estetrol (Fylrevy, Gedeon Richter) to treat postmenopausal women who have estrogen deficiency symptoms and who have either had a hysterectomy or have not had a period for at least 12 months.
Estetrol has been shown to lead to a statistically significant reduction in the frequency and severity of moderate-to-severe menopausal vasomotor symptoms, such as hot flashes and night sweats, compared with placebo.
Estetrol is a sex hormone and modulator of the genital system, which works by substituting for the loss of estrogen production in postmenopausal women.
It will be available as 14.2 mg and 18.9 mg film-coated tablets.
The most common side effects for women who had not undergone a hysterectomy, in combination with progesterone, include endometrial thickening, vaginal hemorrhage, and disordered proliferative endometrium. The other most common side effect, regardless of whether women have undergone a hysterectomy, include breast tenderness and breast pain.
Detailed recommendations for its use will be published on the EMA website after the marketing authorization has been granted.
