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MHRA approves Astellas’ hot flush treatment

The Medicines and Healthcare products Regulatory Agency (MHRA) has licensed VEOZA▼ (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS – also known as hot flushes and night sweats) associated with menopause.

Fezolinetant is the first of a new class of treatments, neurokinin-3 (NK3) receptor antagonists, to be licensed in Great Britain. The non-hormonal mechanism of action targets the neurological cause of VMS in the hypothalamus and represents a breakthrough in an area that has seen limited advances in many years1.

VMS is triggered by an imbalance in the brain’s temperature control centre (the hypothalamus). Before menopause, there is a balance between oestrogens, a female sex hormone, and a protein made by the brain, neurokinin B (NKB), that regulates the brain’s temperature control centre1. As the body goes through menopause, oestrogen levels decline and this balance is disrupted1. Fezolinetant blocks neurokinin B binding in the temperature control centre, preventing the signal which can lead to VMS; reducing the number and intensity of hot flushes and night sweats1.

Hot flushes and night-sweats are common symptoms of menopause and can have a disruptive impact on sleep, daily activities, and overall quality of life2. Moderate to severe VMS in postmenopausal women in the UK has been reported at 40%2.

Dr Timir Patel, Medical Director, Astellas UK said: “The authorisation is testament to the scientific community who have been directly and indirectly involved in developing a targeted way of reducing VMS symptoms.”

Marci English, Vice President, Head of BioPharma Development, Astellas said: “Fezolinetant’s novel mechanism of action targets the root cause of moderate to severe VMS associated with menopause1. We are proud to have developed an innovative treatment option for a condition that has lacked scientific advancement for too long.”

Diane Danzebrink, Founder Director, Menopause Matters said: “Hot flushes and night sweats are common menopause symptoms which can be debilitating, affecting personal health and wellbeing, family lives and careers. It’s welcome news that doctors will have an alternative option to consider during a consultation, according to individual suitability. The decision is particularly important for those who’ve felt overlooked in the past in terms of treatment options, or those who prefer not to use HRT.”

Reference

1 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.

 

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