Shots:
- The CHMP has recommended Fylrevy (estetrol/Donesta) as HRT for oestrogen deficiency symptoms in postmenopausal women, both non-hysterectomised (14.2 mg and 18.9 mg) and hysterectomized (18.9 mg); the decision will be anticipated across EEA markets
- Fylrevy is an oral estetrol-based oestrogen therapy designed to treat a broad range of oestrogen deficiency symptoms, including VMS, in postmenopausal women
- Preclinical and clinical data show that estetrol (E4) has tissue-specific activity with minimal effects on the liver, hemostasis, and breast cell proliferation; its efficacy & safety in reducing VMS were confirmed in two pivotal P-III trials (E4COMFORT I & II) in 2,576 postmenopausal women across multiple regions. E4 is now expanding into menopause therapy
Ref: Gedeon Richter | Image: Gedeon Richter | Press Release
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