Menopause in focus: Innovative therapies and the shift towards individualised women’s health
The women’s health space has long been underfunded and overlooked by organisations across the health research and innovation continuum as a result of stigma and neglect associated with women’s health issues. With growing interest and investment in understanding women’s health needs, coupled to the development of treatments to address these needs, a renaissance in women’s health is underway. An area that is particularly active is menopause care where novel treatment options are beginning to enter the market, with more under development or in the pipeline. These new treatments have the potential to transform the industry and benefit billions of women.
Historically, hormone replacement therapy (HRT) was the standard for treating the vasomotor symptoms (VMS), more commonly known as hot flushes or night sweats, associated with menopause. However, there was a decline in HRT use after the 2002 Women’s Health Initiative trial investigating oestrogen plus progestin hormone therapy in the US, raised safety concerns around the over 20% increase in risk of breast cancer, cardiovascular disease and stroke. As a result, newer practitioners became hesitant to use the treatment creating a 20-year knowledge gap amongst OBGYNs in the use of HRT. With no other treatment options available and a lack of ongoing development in the field at that time, many women were left without effective treatment options.
Change is underway, however. Astellas has secured approval for Veozah, the first non-hormonal option for the treatment of VMS. The drug is likely to soon be joined by Bayer’s non-hormonal candidate, elinzanetant, which has potential market entry in late 2025 following recent FDA and EMA acceptance of NDA submissions in October 2024. These drugs will expand treatment options for individuals with VMS and will be a welcome alternative for HCPs and women who may be wary of HRT or those at risk of breast cancer. Meanwhile, companies such as Dare and Mithra are continuing to develop differentiated hormonal therapies which utilise bioidentical hormones or a synthetic analogue of native oestrogen. This may be more efficacious and safer than the currently available hormones. Further, Pfizer is relaunching its HRT assets, touting that HRT remains the standard of care for menopause-associated VMS.
The focus of treatment strategies is also shifting towards individualised care with practitioners embracing shared and early decision-making which allows women to choose the treatment that best fits their needs. Whilst non-hormonal treatments such as those from Astellas and Bayer will appeal to women who prefer to avoid hormones, hormonal options will remain attractive for those seeking efficacy as well as prevention of issues commonly linked to oestrogen loss during menopause such as osteoporosis and bone loss.
This new attention to the care and management of menopause symptom, such as VMS, represents not only a market opportunity, but a cultural shift toward education and empowerment in women’s health. The increase in available treatment options to manage women’s health signals an important step towards recognition of their needs in the pharmaceutical landscape.
