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A ‘game-changing’ new drug that ‘switches off’ menopausal hot flushes will be available in the UK from January, potentially helping hundreds of thousands of women.
The drug, Veoza, has been approved for use by the Medicines and Healthcare Products Regulatory Agency (MHRA) seven months after it was given the green light in the US.
Hot flushes can affect women during menopause and perimenopause – the period before menopause that can last up to eight years. Those affected feel a sudden flash of warmth across the upper body, particularly across the face, neck and chest.
Flushes can affect sleep and cause discomfort, having knock-on effects in other areas of life.
Now however, it is hoped many of those who suffer hot flushes can avoid them entirely thanks to Veoza, also known as fezolinetant.
Unlike hormone replacement therapy (HRT), the most common treatment for menopausal symptoms, the drug does not act on hormones – making it suitable for a wider range of patients.
Instead, it works by blocking a protein in the brain called neurokinin-3, a key player in regulating body temperature in menopausal women. By ‘switching off’ the protein, hot flushes quickly subside.
‘Hot flushes and night sweats caused by menopause are common, and can have a significant impact on a woman’s daily life,’ said Julian Beach, the interim executive director of healthcare quality and access at the MHRA, speaking to Sky News.
‘We are therefore pleased to have authorised Veoza (fezolinetant) for hot flushes and night sweats caused by menopause via our reliance procedure.
‘No medicine would be approved unless it met our expected standards of safety, quality and effectiveness, and we continue to keep the safety of all medicines under close review.’
While the drug will not address other symptoms of menopause, such as fatigue, muscle weakness and mood swings, it will likely be available to a wider range of patients.
HRT, which replaces the hormones oestrogen and progesterone, is unsuitable for many women, including those with a history of breast cancer, ovarian cancer, blood clots or untreated high blood pressure.
The treatment can also cause side effects including headaches, nausea, vaginal bleeding and depression.
Speaking earlier this year, Professor Waljit Dhillo, an endocrinologist at Imperial College London who led a 2017 trial that led to the new drug’s development, told The Guardian: ‘This is going to be a completely blockbuster drug.
‘It’s like a switch. Within a day or two the flushes go away. It’s unbelievable how well these drugs work. It’s going to be completely game-changing for a lot of women.’
Veoza will initially be available privately on prescription from January 5 for women experiencing menopause-related hot flushes, according to its manufacturer Astellas – although the MHRA noted it has not been studied for safety and efficacy in women over 65.
The price has not yet been revealed, but in the US a 30-day supply costs around £430.
Astellas has reportedly applied to the National Institute for Health and Care Excellence to enable access to the drug on the NHS.
‘It is also worth mentioning that the German firm Bayer, which is one of the other large pharmaceutical companies to retain a focus on women’s health, also has a competing asset in this class under development,’ said Daniel Chancellor, senior healthcare analyst at market intelligence firm Citeline.
‘Its drug, elinzanetant, is completing its late-stage development and could also be on the market within the next two years. Bayer has yet to disclose the results of its most recent study, although a smaller trial showed a comparable reduction in vasomotor symptoms [hot flushes] to Veoza.
‘Success for these drugs is likely to encourage both companies to continue to invest into R&D, and also attract other competitors back to women’s health.’
What are the symptoms of the menopause?
The menopause and perimenopause affects everyone differently, but can have a big impact on your life.
The first sign of perimenopause is usually a change in the normal pattern of your periods.
Common mental health symptoms include low mood, anxiety, mood swings, low self-esteem and brain fog.
Common physical symptoms include:
- Hot flushes, when you have sudden feelings of hot or cold in your face, neck and chest which can make you dizzy
- Difficulty sleeping, which may be a result of night sweats and make you feel tired and irritable during the day
- Palpitations, when your heartbeats suddenly become more noticeable
- Headaches and migraines that are worse than usual
- Muscle aches and joint pains
- Changed body shape and weight gain
- Skin changes including dry and itchy skin
- Reduced sex drive
- Vaginal dryness and pain, itching or discomfort during sex
- Recurrent urinary tract infections (UTIs)
MORE : I went to the UK’s first menopause roadshow and this is what it was like
MORE : I used to have sex once a month, now I’m on HRT I’m doing it in public
MORE : England will beat cervical cancer by 2040, NHS chief says
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