Women’s health – managing the menopause

PME spoke to Marci English, Vice President and Head of BioPharma Development, Astellas, about the importance of new treatments for menopause symptoms, the unmet need and the company’s commitment to midlife women’s health

PME: More than half of women aged 40 to 64 years of age experience vasomotor symptoms (VMS). How are they characterised?
Marci English (ME): VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause that can cause sudden and intense sensations of heat in the face, neck and chest, and last from one to five minutes. They can vary in severity, ranging from mild to moderate to severe, and may be accompanied by sweating, reddening of the skin, chills and rapid heartbeat. A hot flash is defined as mild when there is a sensation of heat without sweating, moderate when there is the sensation of heat with sweating, but the woman can continue her current activity, and severe when the sensation of intense heat with sweating interferes with the continuation of an activity.

PME: The prevalence of moderate-to-severe VMS in postmenopausal women in Europe has been reported as being at 40%. What are some of the most significant challenges women face in their everyday lives?
ME: VMS can have a disruptive impact on women’s daily activities and overall quality of life and are the most common symptom of menopause for which people seek treatment. VMS can last for ten years or more with the average duration being 7.4 years. During this time, the average woman may experience 33 hot flushes and night sweats per week (according to a UK study), though this can vary depending on the person, and can impact many everyday aspects of a woman’s life, including sleep, the ability to focus and personal relationships.

‘VMS can have a disruptive impact on women’s daily activities and overall quality of life and are the most common symptom of menopause for which people seek treatment’

PME: Beyond its physical manifestations, what impact can menopause have on mental well-being?
ME: Menopause can impact women’s mental health, with 76% experiencing irritability, 29% experiencing depression and 14% experiencing anxiety. Forgetfulness, poor concentration, loss of self-esteem and/or confidence, low mood and sadness also can occur.

PME: How does the stigma surrounding menopause affect patient outcomes?
ME: By 2025, an estimated 1.1 billion women worldwide will have experienced menopause or be postmenopausal. Despite the tremendous number of people impacted, conversations about menopause are often limited because of the stigma surrounding it. The resistance to openly discuss the menopause experience may be due to embarrassment or religious or cultural norms. There is also a common misperception among the public that because menopause is a natural part of ageing, nothing can be done about its symptoms, which often leads women to suffer in silence. These stigmas may lead women to avoid talking to their doctor or seeking care for their menopause symptoms.

PME: What treatment options are currently available to alleviate VMS and how have they evolved over the last five years?
ME: Historically, menopause and VMS were believed to be a result of declining oestrogen alone. However, advances in science have increased the understanding of the role of distinct neuronal pathways in the hypothalamus, the part of the brain that regulates body temperature, in causing VMS. This increased understanding has opened the door for innovation in menopause management and treatment.

In December 2023, the European Commission (EC) approved Veoza (fezolinetant) for the treatment of moderate-to-severe VMS associated with menopause. Fezolinetant’s novel mechanism of action targets the root cause of moderate-to-severe VMS associated with menopause. Before menopause, there is a balance between oestrogens, a female sex hormone, and a protein made by the brain known as neurokinin B (NKB) that regulates the brain’s temperature control centre. As the body goes through menopause, oestrogen levels decline and this balance is disrupted, which can lead to VMS. By blocking NKB binding in the temperature control centre, fezolinetant reduces the number and intensity of hot flashes and night sweats.

The safety of fezolinetant has been evaluated in 2,203 women with VMS associated with menopause in phase 3 clinical studies. The most common adverse reactions were diarrhoea (3.2%) and insomnia (3.0%). There were no serious adverse reactions reported at an incidence greater than 1% across the total study population.

Fezolinetant has also been approved as Veozah in the US and as Veoza in Switzerland and the UK.

Alongside fezolinetant, there are a number of prescription and non-prescription treatments for VMS due to menopause. These include hormone replacement therapy (HRT) and non-hormonal therapies, such as selective serotonin-reuptake inhibitors, over-the-counter supplements and herbal therapies, such as soy, black cohosh and other botanicals.

‘Despite the tremendous number of people impacted worldwide, conversations about menopause are often limited because of the stigma surrounding it’

PME: HRT can be used to successfully treat symptoms, but is not recommended in all cases. How can non-hormonal alternatives improve patient outcomes?
ME: While HRT works for some women experiencing menopause symptoms, others may have concerns about the side effects associated with hormone therapy, and other available treatment options may not be suitable for medical reasons. Women want and should have treatment options that take into consideration their medical history and their personal choices. This underscores the need for new prescription non-hormonal treatments that are effective and well tolerated so that these women have options for managing their symptoms. Women should talk with their healthcare provider to understand which treatment option may be best for them.

PME: What gaps remain in menopause care and what is being done to address these?
ME: Despite the tremendous number of people impacted worldwide, treatment advances for those impacted by menopause have been slow to progress, likely due to the stigma surrounding menopause. [As more treatment options become available, hopefully] this will open more doors for women by providing them with other non-hormonal treatment options to control their symptoms.

References are available on request.

Marci English is Vice President and Head of BioPharma Development at Astellas