National Health Service to offer VEOZA▼™ (fezolinetant) for the treatment of moderate-to-severe hot flushes and night-sweats associated with menopause when hormone replacement therapy is unsuitable.

·         Over 2 million women in the UK are affected by moderate to severe hot flushes and night-sweats associated with menopause. 1,2

·         Fezolinetant is the first neurokinin targeted therapy (NK-3 receptor antagonist) to be recommended by NICE.

·         Non-hormonal mechanism of action reduces the frequency and severity of vasomotor symptoms (VMS), also known as hot-flushes and night-sweats in menopause.3

While the term “women” has been used throughout to reflect current clinical guidelines and existing literature, Astellas would like to highlight that the population affected by menopause also includes gender-diverse people who were born female.

Great Britain, March 11, 2026 – Astellas Pharma Ltd today announced that the National Institute for Health and Care Excellence (NICE) issued Final Draft Guidance (FDG) recommending VEOZA™ ▼ (fezolinetant) 45 mg once daily as an option to treat moderate to severe vasomotor symptoms caused by menopause when hormone replacement therapy is unsuitable.^[4] The recommendation provides another path for women seeking management of hot flushes and night-sweats, supporting more personalised menopause care.

Hot flushes and night sweats are a common symptom of menopause and may significantly disrupt quality of life.^1,5 They are known to worsen other symptoms of menopause, including sleep quality, work productivity, energy, anxiety and mood.^[5] Fezolinetant reduces the frequency and intensity of hot flushes and night sweats by selectively blocking a neurotransmitter (neurokinin B) in the brain that is involved in causing hot flushes.^3,[6],[7]

Dr Timir Patel, Medical Director, Astellas, UK

“Emerging real-world evidence on the use of fezolinetant shows how effectively managing hot flushes and night-sweats can positively affect sleep quality, work productivity, and overall daily functioning. With many women in the UK still under-served by available treatment options when HRT is deemed unsuitable, this recommendation provides another option for those suffering from moderate to severe vasomotor symptoms associated with menopause.”

Dr Vikram Talaulikar, Associate Specialist, Reproductive Medicine, University College London Hospitals and Honorary Associate Professor at University College London.

“Despite progress, the sad reality is that many women continue to suffer in silence as not all current treatments meet their specific needs. NICE’s decision means that NHS doctors now have an alternative treatment that was specifically designed and studied to improve particular symptoms of menopause. It is excellent news for the furtherment of women’s health in the UK and provides women with a wider choice of options.”

Anita Powell, Founder, The Menopause Alliance

“In community settings, I meet women every week who are struggling with debilitating menopausal symptoms and limited treatment options. NICE’s guidance recognises this reality. The next step must be ensuring that local services are equipped to deliver timely, informed care so women do not continue to fall through the gaps.”

The guidance from NICE was based on data from the BRIGHT SKY™ programme, which included three randomised Phase 3 clinical trials as part of a development programme that collectively enrolled over 2,800 across Europe, the U.S. and Canada. Results from the SKYLIGHT 1™ and SKYLIGHT 2™ pivotal trials characterise the efficacy and safety of fezolinetant versus placebo 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.^[8],[9] Data from the SKYLIGHT 4™ safety study further characterises the long-term safety profile of fezolinetant and was published in Obstetrics & Gynecology.^[10]

References

1.    Kiran et al. Epidemiology and treatment patterns of UK women diagnosed with vasomotor symptoms: Findings from the Clinical Practice Research Datalink GOLD database. Maturitas. 2022 Oct:164:1-8. doi: 10.1016/j.maturitas.2022.05.013. Epub 2022 Jun 9.

2.    Astellas. Data on File

3.    Electronic Medicines Compendium, Summary of Product Characteristics (SPC/SmPC) for fezolinetant in Great Britain: www.medicines.org.uk

4.    NICE Final Draft Guidance - Fezolinetant for treating vasomotor symptoms associated with the menopause [ID5071]

5.    Islam et al. Prevalence and severity of symptoms across the menopause transition: cross-sectional findings from the Australian Women's Midlife Years (AMY) Study. The Lancet Diabetes & Endocrinology. 2025. https://doi.org/10.1016/S2213-8587(25)00138-X

6.    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. 

7.    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. 

8.    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. 2023. doi:10.1016/S0140-6736(23)00085-5.

9.    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.

10.  Neal-Perry G, Cano A, Lederman S, et al. Safety of fezolinetant for vasomotor symptoms associated with menopause: a randomized controlled trial. Obstetrics & Gynecology. 2023. doi:10.1097/AOG.0000000000005114.