• 03 Feb 2026
• Admin
• News Article

EMA’s CHMP Recommends Approval of Gedeon Richter’s Fylrevy for Menopause Hormone Therapy

Gedeon Richter Plc. announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Fylrevy (estetrol, E4) as a hormone replacement therapy (HRT) for postmenopausal women with oestrogen deficiency symptoms.

If approved by the European Commission, Fylrevy could become the first innovative hormonal menopause therapy introduced in Europe in decades.

Who Fylrevy Is For?

CHMP recommends Fylrevy for:

• Non-hysterectomised postmenopausal women
  • At least 12 months since last menses
  • Fylrevy 14.2 mg and 18.9 mg doses
• Hysterectomized postmenopausal women
  • Fylrevy 18.9 mg dose

The final decision now moves to the European Commission, which will determine marketing authorization across the European Economic Area (EEA).

Why This Decision Matters?

Menopause affects millions of women and is often associated with:

• Hot flushes and night sweats (vasomotor symptoms, VMS)
• Vulvo-vaginal atrophy (VVA)
• Sleep disturbances
• Mood changes, anxiety, and depression
• Cognitive changes
• Urinary incontinence
• Musculoskeletal symptoms and bone health decline

Up to 80% of menopausal women experience VMS, with symptoms lasting an average of 7–9 years.

Fylrevy is designed to address a broad spectrum of oestrogen deficiency symptoms, including VMS.

About Estetrol (E4)

Estetrol is:

• A native oestrogen produced by the foetal liver during pregnancy
• Synthesized from plant sources for pharmaceutical use
• Characterized by tissue-specific activity and a more selective pharmacological profile

Clinical and preclinical data suggest E4 has:

• Low impact on liver function
• Limited effect on haemostasis balance
• Reduced stimulation of breast cell proliferation

Phase 3 Evidence Base

The efficacy and safety of Fylrevy were demonstrated in two pivotal Phase 3 trials:

• E4COMFORT I
• E4COMFORT II

Key facts:

• 2,576 postmenopausal women enrolled
• Conducted across Europe, Russia, USA, Canada, and Latin America
• Confirmed significant reduction in vasomotor symptoms

Estetrol’s Expanding Clinical Footprint

Estetrol is already:

• Approved in 50+ countries
• Used as the oestrogen component in a combined oral contraceptive with drospirenone
• Marketed in the EU as Drovelis

Fylrevy expands the compound’s use into menopause care.

Company Perspective

Dr. Péter Turek, Head of Women’s Healthcare at Richter, said:

“Following European Commission approval, Fylrevy may become the first innovative hormonal therapy for menopause in the European market in decades. This milestone reflects our commitment to original research and improving the quality of life of women globally.”

About Gedeon Richter

Founded in 1901 and headquartered in Hungary, Gedeon Richter is a global pharmaceutical company focused on:

• Women’s healthcare
• Neuropsychiatry
• Biotechnology
• General medicines

The company operates Central Europe’s largest R&D hub and reported:

• EUR 2.2 billion in sales (2024)
• EUR 4.7 billion market capitalization