Astellas' VEOZA OKd by EC for Treatment of Vasomotor Symptoms in Menopause

 First-in-class treatment option reduces number and intensity of hot flashes and night sweats 

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the European Commission (EC) on December 7 approved VEOZATM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 

VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause.1,2 Worldwide, more than half of women 40 to 64 years of age experience VMS, with rates in Europe ranging from 56% to 97%.3,4,5 The prevalence of moderate to severe VMS in postmenopausal women in Europe has been reported at 40%.6 VMS can have a disruptive impact on women's daily activities and overall quality of life.

Before menopause, there is a balance between estrogens, a female sex hormone, and a protein made by the brain known as neurokinin B (NKB) that regulates the brain's temperature control center. As the body goes through menopause, estrogen levels decline and this balance is disrupted, which can lead to VMS. By blocking NKB binding in the temperature control center, fezolinetant reduces the number and intensity of hot flashes and night sweats.

This approval follows a positive opinion issued in October by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based on the results from the BRIGHT SKY™ program, which included three Phase 3 clinical trials as part of a development program that collectively enrolled over 3,000 across Europe, the U.S. and Canada. Results from the SKYLIGHT 1™ and SKYLIGHT 2™ pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause and were published in The Lancet and The Journal of Clinical Endocrinology & Metabolism, respectively.7,8 Data from the SKYLIGHT 4™ safety study further characterizes the long-term safety profile of fezolinetant and was published in Obstetrics & Gynecology.9

The EC marketing authorization for fezolinetant is applicable in the European Union (EU) Member States, as well as Iceland, Norway and Liechtenstein.10 Fezolinetant was also approved in Switzerland on December 4, 2023.

Astellas has already reflected the impact from this matter in its financial forecast of the current fiscal year ending March 31, 2024.

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