After decades of neglect, menopause and the impact it has on women’s life quality 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 roughly a third of the female population. The most common symptom is hot flushes, which, in addition to fatigue, mood swings and muscle weakness, can seriously impact women’s wellbeing and productivity.
Dr Sigi Joseph, who is a GP and leading expert on treating menopause says, “Perimenopausal and menopausal women are the fastest-growing workforce and we are losing one in 10 to symptoms, therefore it has huge socioconomic impacts. Focusing research and developing on supporting these women will have far-reaching benefits.”
Women seeking help to managing their menopausal symptoms have had few options. The most widely used treatment, hormone replacement therapy (HRT), is effective, but can’t be used in most of those with a history of ovarian or breast cancer, blood clots or untreated high blood pressure. In addition, taking oestrogen and progesterone has side effects that some women struggle to tolerate. The option facing doctors has been prescribing 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 across the world. Data published in the Lancet shows that in women aged 40 to 65 taking the drug over 12 weeks reduced both the frequency and severity of hot flushes compared with those taking 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 responsible for temperature regulation. These neurons are largely controlled by the hormone oestrogen, and when levels fall during menopause they become enlarged. Unable to assess the real temperature of the body, they release the protein neurokinin-B, which triggers hot flushes. Veoza works by containing a compound that binds to these neurons and blocks the release of the proteins (which are responsible for triggering hot flushes).
As with all drugs, it’s not without side effects, such as liver damage, abdominal pain, diarrhoea and back pain. When approving Veoza in the US in May 2023, the FDA recommended that before using it all patients should have blood tests to check for liver damage, then routine blood tests every three months to assess its impact on the body. It is also a new drug, which means longer-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 being safe and effective, it has not been recommended to be offered through the NHS yet. The main barrier is cost: developed by a Japanese pharmaceutical company, Veoza is a daily pill that costs, in the US, $550 (£430) 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 assess the health benefits of the drug versus the cost, and come to a recommendation on whether it justifies spending public sector money on it.
While being called a “blockbuster” drug, this isn’t a “cure” for menopause and its full impact on the body. It’s a huge step forward in alleviating one major symptom, but there’s much more to be done in this area. And it hasn’t yet been approved in Britain for those over 65, as they weren’t included in the trial.
It does seem surprising that in 2023 the options available to doctors have been so limited to help their patients. But this has also been the case for birth control and for pregnant women facing severe morning sickness. Women have often been told just to “get on with it”, especially if the underlying issue is “just hormones”. The result has been limited treatment options for those suffering from symptoms that affect their daily life. A condition has to be defined as a problem before research funding flows to understand it and solutions are developed based on that science.
But the tide is turning, with increased research investment into understanding the underlying biology causing these changes, and developing treatments to target these cellular processes. Hopefully Veoza is the first of many drugs developed. But as the high price clearly shows, developing and approving a medicine is half the story. The other half is working with pharmaceutical companies to bring down the price to make it affordable and accessible to all women who want to have access. Otherwise, it makes great headlines, but doesn’t change much for those struggling to sleep at night and get through their day.
Prof Devi Sridhar is chair of global public health at the University of Edinburgh
