Aafter decades of neglect, menopause and the impact it has on women’s quality of life is becoming a major focus of pharmaceutical research. Hence the excitement this week about a new, potentially life-changing, drug.
Part of this is the growing recognition of what a huge market it is: the NHS estimates that 13 million women are currently peri- or menopausal in the UK, which is around a third of the female population. The most common symptom is hot flashes, which, in addition to fatigue, mood swings and muscle weakness, can seriously affect women’s well-being and productivity.
Dr Sigi Joseph, a general practitioner and leading expert in the treatment of menopause, says: “Women in perimenopause and menopause are the fastest growing workforce and we lose one in 10 to symptoms, so this has huge socio-economic impacts. focusing and developing research to support these women will have far-reaching benefits.”
Women seeking help to manage their menopausal symptoms had few options. The most commonly used treatment, hormone replacement therapy (HRT), is effective but cannot be used in most of those with a history of ovarian or breast cancer, blood clots, or untreated high blood pressure. In addition, taking estrogen and progesterone has side effects that some women find difficult to tolerate. The option facing doctors was to prescribe HRT or nothing.
The high demand for help with menopausal symptoms versus the limited medical solutions and the lack of support available is why the news of a new drug called Veoza, or fezolinetant, has made headlines around the world. Data published in the Lancet shows that in women between the ages of 40 and 65 using the drug over 12 weeks, both the frequency and severity of hot flashes decreased compared to those who took a placebo. Participants were recruited from different ethnic backgrounds, with the findings indicating that the drug works equally well in black, Asian, Latina and white women.
Veoza works by targeting specific neurons in the brain that are responsible for temperature regulation. These neurons are largely controlled by the hormone estrogen, and when levels drop during menopause they enlarge. Unable to determine the actual temperature of the body, they release the protein neurokinin-B, which causes hot flashes. Veoza works by containing a compound that binds to these neurons and blocks the release of the proteins (responsible for causing hot flashes).
As with all drugs, it is not without side effects, such as liver damage, abdominal pain, diarrhea and back pain. When Veoza was approved in the US in May 2023, the FDA recommended that before using it, all patients should undergo blood tests to check for liver damage, and then routine blood tests every three months to determine its impact on the body. It’s also a new drug, which means long-term data will come with its use in the population.
Will we see its rollout in the NHS? While the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the drug as safe and effective, it has not yet been recommended for use by the NHS. The main obstacle is cost: Veoza, developed by a Japanese pharmaceutical company, is a daily pill that costs $550 (£430) in the US for a 30-day supply. Given a limited budget, and many competing priorities and conditions, the National Institute for Health and Care Excellence (Nice) will evaluate the health benefits of the drug against the costs, and come to a recommendation as to whether it is worth spending money from the public sector fair to it. .
Although it is called a “blockbuster” drug, it is not a “cure” for menopause and its full impact on the body. It is a big step forward to alleviate one major symptom, but there is still much more to be done in this area. And it has not yet been approved in Britain for those over 65, as they were not included in the trial.
It does seem surprising that the options available to doctors in 2023 were so limited to help their patients. But this was also the case for birth control and for pregnant women to face severe morning sickness. Women are often told to just “get on with it”, especially if the underlying problem is “just hormones”. The result has been limited treatment options for those suffering from symptoms that affect their daily lives. A condition must be defined as a problem before research funding flows to understand it and develop solutions based on that science.
But the tide is turning, with increased research investment in understanding the underlying biology that causes these changes, and the development of treatments to target these cellular processes. Hopefully, Veoza is the first of many drugs to be developed. But as the high price clearly shows, the development and approval of a medicine is only half the story. The other half is working with pharmaceutical companies to bring the price down to make it affordable and accessible to all women who want access. Otherwise, it makes good news, but doesn’t change much for those who struggle to sleep at night and get through their day.
