The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the use of the drug Fylrevy (estetrol, E4) as hormone replacement therapy for symptoms of estrogen deficiency in postmenopausal women. This was reported to GxP News by the press service of the Hungarian manufacturer Gedeon Richter.
This is the second drug created based on the estetrol molecule with selective action (having less impact on the liver and blood vessels compared to previous-generation estrogens), the commercialization rights for which in Europe and the CIS belong to Gedeon Richter. The first — Drovelis (sold in Russia under the brand Esteretta) — is a combined hormonal contraceptive for oral use, containing estetrol (14.2 mg) and drospirenone (3 mg).
“The European Commission will consider the recommendation to make a final decision on the drug registration application. This decision will apply to all member states of the European Economic Area,” the company stated.
Péter Turek, Head of the Women’s Healthcare Business Unit at Gedeon Richter, noted that Fylrevy could become “the first innovative hormonal therapy for menopause on the European market in decades.”
Oral estrogen therapy based on estetrol is intended for treating a wide range of estrogen deficiency symptoms in postmenopausal women, including vasomotor symptoms. Estetrol is a native estrogen produced by the fetal liver during pregnancy, which for pharmaceutical purposes is synthesized from plant sources. Data from preclinical and clinical studies of E4 indicate tissue-specific activity and a more selective pharmacological profile compared to other estrogens, including low impact on the liver, hemostasis balance, and breast cell proliferation.