Richter Hormone Replacement Therapy Drug Near Approval

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Hungarian pharmaceutical company Gedeon Richter's drug FYLREVY as hormone replacement therapy for estrogen deficiency symptoms, Richter said on Friday.

The European Commission will review the CHMP recommendation for a final decision on the marketing authorisation application to be applicable to states in the European Economic Area.

Estetrol-based FYLREVY is designed to treat the broad spectrum of estrogen deficiency symptoms in postmenopausal women.

Dr. Péter Turek, Head of Women’s Healthcare (WHC) Business Unit, is quoted in the statement as saying that “we are delighted to receive the positive CHMP opinion for FYLREVY® - an important milestone in addressing a substantial unmet need in menopause care, a condition impacting millions of women worldwide. Following the approval of the European Commission, FYLREVY® may be the first innovative hormonal therapy for menopause in the European market in decades. Bringing an original product to the market – our second, based on the unique, proprietary Estetrol platform – would be a major achievement for Richter. It reflects our unwavering commitment to improving the quality of life of women globally, validates our strategy to invest in original research, and further strengthens our leading position in Europe.”