Richter Gedeon moves its estrogen therapy FYLREVY toward US market approval

Richter Gedeon reported that the US Food and Drug Administration has formally accepted its application for FYLREVY, an oral estrogen formulation that uses Estetrol (E4) to treat moderate to severe vasomotor symptoms associated with menopause. The regulator is expected to issue its decision by the third quarter of 2027, which would position FYLREVY as the first E4-based hormone therapy approved in the United States. The drug received a marketing authorization from the European Commission in March 2026 and is currently marketed in Hungary, the Czech Republic, Slovakia, Finland and Sweden.

FYLREVY is indicated for post-menopausal women who have not undergone hysterectomy and for those who have, with dosage options of 14.2 mg, 18.9 mg, or a single 18.9 mg strength for hysterectomised patients. Dr. Turek Péter, head of the gynecology business unit, said the FDA filing reflects Richter’s dedication to addressing a large, underserved health need worldwide. The company aims to make the therapy available to American patients as part of its broader mission to advance women’s health globally.