A groundbreaking menopause therapy could change the quality of life for women in Europe.

 

Pharma innovator Gedeon Richter has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of FYLREVY (Estetrol; developed as DONESTA) for hormone replacement therapy (HRT).

 

The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses, and FYLREVY 18.9 mg for hysterectomized postmenopausal women. The European Commission will now review the CHMP’s recommendation to make a final decision on marketing authorization across all European Economic Area member states.

 

Dr Péter Turek, Head of Women’s Healthcare Business Unit at Richter, said: "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.”

 

He added: “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.”