- Fezolinetant is a first-in-class[1] selective neurokinin 3 receptor antagonist providing a nonhormonal option to reduce moderate to severe VMS associated with menopause.
- VMS affects more than 50% of women aged 40 to 64 years globally[2]
Astellas Pharma Co Ltd. Ireland today announced that VeozaTM (fezolinetant) 45 mg film-coated tablets for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause1 is now available in Ireland.
VMS, characterised by hot flushes (also called hot flashes) and/or night sweats, is a common symptom of menopause.[3],[4] Worldwide, more than half of women 40 to 64 years of age experience VMS with rates in Europe ranging from 56% to 97%.2,3,[5]The prevalence of moderate to severe VMS in postmenopausal women in Europe has been reported at 40%.4 VMS can have a disruptive impact on women’s daily activities and overall quality of life.3
The approval is based on the results from the BRIGHT SKY™ program, which included three Phase 3 clinical trials that collectively enrolled over 3,000 individuals across Europe, the U.S., and Canada.[6],[7]
Dr. Deirdre Lundy, Clinical Lead in the Complex Menopause Service, The National Maternity Hospital Dublin said: “I’m delighted to see the availability of Fezolinetant in Ireland. This advancement in women’s health provides a novel, non-hormonal option for menopausal women to control their moderate to severe VMS – symptoms which can be so debilitating and which have a huge impact on these women’s daily lives.”
Fezolinetant was first approved by the European Medicines Agency (EMA) in December 2023 for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.1
About Fezolinetant
Fezolinetant is oral, nonhormonal medicine indicated for the treatment of moderate to severe VMS associated with menopause. VMS are also known as hot flushes or night sweats. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy), helping restore the balance in the brain’s temperature control center (the hypothalamus) to reduce the number and intensity of hot flushes and night sweats.[8],[9],[10]
About VMS Associated with Menopause
VMS, characterised by hot flushes (also called hot flashes) and/or night sweats, is a common symptom of menopause.3,4 Worldwide, more than half of women 40 to 64 years of age experience VMS with rates in Europe ranging from 56% to 97%.2,[11],[12] The prevalence of moderate to severe VMS in postmenopausal women in Europe has been reported at 40%.[13] VMS can have a disruptive impact on women’s daily activities and overall quality of life.3
About the BRIGHT SKY Phase 3 Program
The BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155) and SKYLIGHT 2 (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within Europe, the U.S., and Canada. SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within Europe, the U.S., and Canada.
About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
Contacts for inquiries or additional information:
Astellas Pharma Ireland Communications
Valerie Quine
Executive & Communications Assistant
References
[1] EMA.Europa, Veoza (fezolinetant) An overview of Veoza and why it is authorized in the EU, Available from: https://www.ema.europa.eu/en/documents/overview/veoza-epar-medicine-overview_en.pdf [Accessed 27 March, 2023]
[2] Makara-Studzinska MT, Krys-Noszczyk KM, Jakiel G. Epidemiology of the symptoms of menopause – an intercontinental review. Przegl Menopauzalny [Menopause Rev]. 2014;13:203-211.
[3] Williams RE, Kalilani L, DiBenedetti DB, et al. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Climacteric. 2008;11:32-43.
[4] Nappi RE, Kroll R, Siddiqui E, et al. Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden. Menopause. 2021;28:875-882.
[5] Gold EB, Colvin A, Avis N, et al. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women’s health across the nation. Am J Public Health. 2006;96:1226-1235.
[6] Lederman S, Ottery F, Cano A et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. The Lancet. March 13, 2023. doi:10.1016/S0140-6736(23)00085-5.
[7] Johnson K, Martin N, Nappi R et al. Efficacy and safety of fezolinetant in moderate-to-severe vasomotor symptoms associated with menopause: A Phase 3 RCT. The Journal of Clinical Endocrinology & Metabolism. 2023;00:1-17.
[8] Depypere H, Timmerman D, Donders G, et al. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. J Clin Endocrinol Metab. 2019;104:5893-5905.
[9] Fraser GL, Lederman S, Waldbaum A, et al. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Menopause. 2020;27:382-392.
[10] Fraser GL, Hoveyda HR, Clarke IJ, et al. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. Endocrinology. 2015;156:4214-4225.
[11] Gold EB, Colvin A, Avis N, et al. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women’s health across the nation. Am J Public Health. 2006;96:1226-1235.
[12] Williams RE, Kalilani L, DiBenedetti DB, et al. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Climacteric. 2008;11:32-43.
[13] Nappi RE, Kroll R, Siddiqui E, et al. Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden. Menopause. 2021;28:875-882.
