Gedeon Richter Media Richter Receives Positive CHMP Opinion for FYLREVY® (Estetrol tablet)
Richter Receives Positive CHMP Opinion for FYLREVY® (Estetrol tablet)
30/01/2026
Gedeon Richter Plc. (“Richter”) announces today that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has adopted a positive opinion recommending approval of FYLREVY® (Estetrol; developed under the name DONESTA®) as Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in non-hysterectomised postmenopausal women with at least 12 months since last menses (FYLREVY® 14.2 mg and 18.9 mg) and as HRT for oestrogen deficiency symptoms in hysterectomized postmenopausal women (FYLREVY® 18.9 mg).

The European Commission (“EC”) will review the CHMP recommendation for making a final decision on the Marketing Authorization Application. The decision will be applicable to all member states of the European Economic Area.

Dr. Péter Turek, Head of Women’s Healthcare (WHC) Business Unit, commented: “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.”

About Menopause

Menopause is a natural biological process marking the end of a woman's reproductive years, typically occurring between 45 and 55 years old. It is characterized by the cessation of menstruation due to decreased production of oestrogens and progesterone by the ovaries. 

The most frequently reported symptoms include vasomotor symptoms (VMS, which include hot flushes and night sweats), vulvo-vaginal atrophy (VVA), sleep disturbances, impaired bone health, physical changes (amongst which musculoskeletal symptoms, weight gain, thinning hair and dry skin), mood changes (including increased irritability, anxiety and depression), urinary incontinence, and cognitive changes.

VMS are among the most common and bothersome menopausal complaints, and one of the main reasons why women may seek medical care for the menopause. Hot flushes are characterized by sudden sensations of heat in the upper body, that last for 2 to 4 minutes and repeat multiple times each day. Up to 80% of menopausal women suffer from VMS, which have a mean duration of 7 to 9 years. 

About FYLREVY®

The orally administered Estetrol-based oestrogen therapy FYLREVY® is designed to treat the broad spectrum of oestrogen deficiency symptoms in postmenopausal women, including VMS. Estetrol (E4) is a native oestrogen produced by the foetal liver during pregnancy and is synthesized from plant sources for pharmaceutical purposes. Preclinical and clinical data for E4 points to a tissue-specific activity and a more selective pharmacological profile compared to other estrogens, including a low impact on the liver, hemostasis balance and breast cell proliferation. The efficacy and safety of E4 in alleviating VMS was evaluated in two independent, confirmatory, pivotal phase 3 studies (E4COMFORT I and E4COMFORT II) having enrolled a total of 2576 postmenopausal women in Europe, Russia, United States of America (USA), Canada and Latin America. In addition to its authorization in over 50 countries worldwide as the oestrogen component of a combined oral contraceptive with drospirerone (marketed as DROVELIS® in EU), E4 is now further expanding its therapeutic reach in the menopause field.

About Richter

Richter aspires to be a global innovator in some key scientific fields, while dedicated to making medicines more accessible worldwide. Founded in 1901, headquartered in Hungary, with a market capitalization of EUR 4.7bn and sales of EUR 2.2bn in 2024, it operates Central Europe's largest R&D hub. Its research drives breakthroughs in Neuropsychiatry and Women's Healthcare, while Biotechnology and General Medicines strengthen its affordable treatment portfolio. Committed to sustainable growth, Richter invests in R&D, manufacturing excellence, and digitalization to advance medical innovation. Learn more at www.gedeonrichter.com

FYLREVY® and DONESTA® are registered trademarks of Estetra SRL, a wholly owned subsidiary of Gedeon Richter Plc. DROVELIS® is a registered trademark of Gedeon Richter Plc. Any unauthorized use is expressly prohibited.

 

For further information:

Investors:        Róbert Réthy, CFA                                                                 +36 20 342 2555 

Media:             Zsuzsa Beke                                                                           +36 20 916 4507