- Astellas’ VEOZA™ (fezolinetant) is now approved in Australia for the treatment of moderate to severe vasomotor symptoms (VMS, known as hot flushes and night sweats) associated with menopause.1
- Up to 80% of women experience VMS during the menopausal transition,2 ranging in severity from mild, moderate to severe.3,4
- Around 385,000 Australian women aged 40-64 years with moderate to severe VMS are not receiving treatment.5
SYDNEY, Friday 5 April, 2024 – Astellas Pharma Australia Pty Ltd today announced that first-of-its-kind non-hormonal treatment, VEOZA™ (fezolinetant),6 has been approved for use in Australia for the treatment of vasomotor symptoms (VMS) associated with menopause.1 VMS are commonly referred to as hot flushes and night sweats.
Up to 80% of women experience VMS during the menopausal transition,2 these can range in severity from mild, moderate to severe.3,4 For most people, VMS due to menopause lasts for ~7.4 years.2 In some cases, VMS may last longer than 10 years.2 The impact of VMS on overall health and wellbeing can be significant. Data shows that women who experience frequent VMS experience higher rates of anxiety, depression, difficulty sleeping and overall impaired quality of life that may impact the ability to work and carry out day-to-day activities.7,8 Despite these profound impacts, a study of Australian women aged 40-64 years showed that 85% of women with moderate to severe VMS are not currently receiving treatment, or around 385,000 women.5
“We know that stigma and other barriers prevent many women from having conversations with their doctor,” said Professor Rodney Baber, Head of Menopause and Menstrual Disorders Clinic at the Royal North Shore Hospital in Sydney. “Hot flushes and night sweats associated with menopause can be very disruptive, affecting a person’s sleep, mood, energy and overall quality of life, with some women experiencing symptoms for ten years or more. Women should talk to their doctor about managing symptoms in ways that suit their medical history and personal preferences.”
“Approval of VEOZA means we have a new non-hormonal treatment option available for women experiencing these disruptive symptoms,” said Professor Baber.
Before menopause, there is a balance between the hormone oestrogen and a certain brain chemical (neurokinin B) which regulates the body’s temperature control centre.9 As the body goes through menopause, oestrogen levels decrease, and this balance is disrupted, which leads to VMS.9 Moderate VMS include the sensation of heat with sweating, while severe VMS involve intense sensations of heat with sweating that interferes with the continuation of an activity.10
VEOZA works by blocking neurokinin B binding in the body’s temperature control centre to reduce the number and intensity of VMS.11,12,13 It is given as a once-daily oral pill.13
“We welcome the approval of VEOZA, a first-of-its-kind non-hormonal treatment1,6 option based on the biology behind hot flushes,” said Christine Kemp, Senior Medical Lead at Astellas Australia. “Today’s approval marks an important step in increasing the choices available to women experiencing some of the most bothersome symptoms of menopause. At Astellas, we are proud to be delivering innovative therapies in areas of unmet need."
In addition to the approval in Australia, VEOZA has also been approved for treatment of VMS in the United States, the United Kingdom and by the European Commission.
For further information about menopause and management options to suit their individual circumstances, people should speak to their general practitioner.
– ENDS –
Full Consumer Medicines Information can be accessed at: VEOZA™ (medsinfo.com.au)
Astellas Pharma Australia Pty Ltd
Suite 2.01, 2 Banfield Road, Macquarie Park, NSW 2113
Astellas Medical Information Contact: 1800 751 755 or aaumedinfo@astellas.com
Date of first inclusion on ARTG: 26 February, 2024
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.
References
1 Australian Register of Therapeutic Goods. VEOZA (fezolinetant) Available from: https://www.tga.gov.au/resources/artg/401401] [Accessed February 2024].
2 Avis NE, Crawford SL, Green R. Vasomotor Symptoms Across the Menopause Transition: Differences Among Women. Obstet Gynecol Clin North Am. 2018 Dec;45(4):629-640. doi: 10.1016/j.ogc.2018.07.005. Epub 2018 Oct 25. PMID: 30401547; PMCID: PMC6226273.
3 Thurston RC. Vasomotor symptoms. In: Crandall CJ, Bachman GA, Faubion SS, et al., eds. Menopause Practice: A Clinician's Guide. 6th ed. Pepper Pike, OH: North American Menopause Society, 2019;43-55.
4 Guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women. EMA. https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-hormone-replacement-therapy-oestrogen-deficiency-symptoms. Accessed July 07, 2023
5 Worsley R, Bell RJ, Gartoulla P, Davis SR. Low use of effective and safe therapies for moderate to severe menopausal symptoms: a cross-sectional community study of Australian women. Menopause. 2016 Jan;23(1):11-7. doi: 10.1097/GME.0000000000000495. PMID: 26240945.
6 Australian Register of Therapeutic Goods. Search the TGA website. Available from: https://www.tga.gov.au/search?keywords=NK3&submit=Search [Accessed March 2024]
7 Khan SJ, Kapoor E, Faubion SS, Kling JM. Vasomotor Symptoms During Menopause: A Practical Guide on Current Treatments and Future Perspectives. Int J Womens Health. 2023 Feb 14;15:273-287. doi: 10.2147/IJWH.S365808. PMID: 36820056; PMCID: PMC9938702.
8 Nappi RE, Kroll R, Siddiqui E, Stoykova B, Rea C, Gemmen E, Schultz NM. Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden. Menopause. 2021 May 24;28(8):875-882. doi: 10.1097/GME.0000000000001793. Erratum in: Menopause. 2022 Jun 01;29(6):759. PMID: 34033602; PMCID: PMC8746897.
9 Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin Investig Drugs 2021;30(7):681-94.
10 Center for Drug Evaluation and Research. Draft Guidance. Estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms – recommendations for clinical evaluation. (January 2003). Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/estrogen-and-estrogenprogestin-drug-products-treat-vasomotor-symptoms-and-vulvar-and-vaginal-atrophy. [Accessed February 2024]
11 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.
12 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.
13 Consumer Medicine Information – VEOZA™ (fezolinetant). Available at VEOZA™ (medsinfo.com.au) [Accessed March 2024].
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