Menopause
UK first to approve non-hormonal menopause drug
The UK has become the first country in the world to approve elinzanetant, a non-hormonal treatment for moderate to severe hot flushes linked to menopause.
The once-daily oral capsule, branded Lynkuet, works by calming overactive brain signals that interfere with the body’s temperature control when oestrogen levels fall.
Hot flushes and night sweats occur when certain brain cells become overactive, disrupting the body’s ability to regulate heat.
The Medicines and Healthcare products Regulatory Agency (MHRA) approved the medicine on 8 July for women who cannot, or choose not to, take hormone-based therapies.
The approval is based on results from the OASIS clinical trials involving more than 1,400 women aged 40 to 65 in several countries. The studies showed that a daily 120mg dose significantly reduced the frequency and severity of hot flushes and night sweats over a period of 26 to 52 weeks, compared to a placebo.
The treatment may also help relieve sleep disturbances commonly associated with menopause.
Julian Beach, MHRA interim executive director of healthcare quality and access, said: “Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life.
“We are therefore pleased to announce our approval of elinzanetant, which has met the MHRA’s standards for safety, quality and effectiveness.
“Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies.
“As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.”
The marketing authorisation was granted to Bayer plc following an Access Consortium new active substance work-sharing initiative.
The MHRA is an executive agency of the Department of Health and Social Care, responsible for regulating all medicines and medical devices in the UK.
Menopause
Medichecks acquires My Menopause Centre to expand specialist hormone health services
Digital diagnostics company Medichecks has acquired specialist menopause health platform and clinic My Menopause Centre.
The deal is part of Medichecks’ move into clinical services and follows its earlier purchase of Leger Clinic, creating what the company describes as a hormone health offering for women and men across the UK.
Medichecks and My Menopause Centre will combine digital services with clinical governance. The acquisition aims to enhance Medichecks’ ability to deliver integrated testing, diagnosis and ongoing clinical support.
The combined group plans to grow its specialist hormone health services, supporting patients across the UK with clinical care throughout different stages of their hormone health journey.
Helen Marsden, co-founder of Medichecks, said: “At Medichecks, our mission is to make healthcare more accessible, evidence-based and patient-centred.
“Helen and Clare have built an outstanding, clinically credible platform that is transforming menopause care for women across the UK.
“Medichecks now owns two CQC Outstanding-rated clinics, the only clinics in their respective sectors to achieve this rating, and we are deeply committed to delivering safe, compassionate and patient-centric care.
“We’re proud to continue the founders’ legacy while supporting the next stage of growth, ensuring more women can access high-quality menopause care when they need it most.”
The CQC, or Care Quality Commission, is the independent regulator of health and social care in England.
The acquisition supports Medichecks’ plans to make hormone healthcare more accessible by delivering integrated testing, diagnosis and ongoing clinical support for patients across the UK.
Helen Normoyle, co-founder and chief executive of My Menopause Centre, said: “We set out to build something resilient, clinically credible and scalable, not just fast.
“Our mission has always been to make menopause care compassionate, accessible and grounded in evidence. Medichecks shares that vision.
“Their digital platform, commitment to clinical excellence and patient-centred care make them the ideal partner to take My Menopause Centre into its next chapter.
“This milestone reflects not only a strong product, but a remarkable team and community.
“I’m deeply proud of what we’ve built and excited to see My Menopause Centre grow further under Medichecks’ leadership.”
Menopause
Menopause specialist Haver joins Midi Health
Menopause specialist Dr Mary Claire Haver has been appointed as the first chief agewell officer at virtual care clinic Midi Health.
In the role, Dr Haver will work with Midi’s clinical team to develop the AgeWell platform, described as a proactive health model that integrates perimenopause and menopausal care with metabolic health, bone density, brain health and cardiovascular risk assessment.
The platform aims to provide preventative care targeting what the company describes as the primary drivers of female mortality and disability: heart disease, bone loss and cognitive decline.
Joanna Strober, chief executive and co-founder of Midi Health, said: “Longevity care has historically ignored women’s biology, especially during the critical windows of midlife and menopause.
“At Midi Health, we are committed to extending healthspan, not just lifespan, and making that care accessible to millions of women as a core pillar of their health.
“By collaborating with Dr Haver, we are ensuring women continue to have access to care designed for their bodies, their hormones, and their real lives.”
Dr Haver is board-certified in obstetrics and gynaecology, a Menopause Society certified practitioner, a certified culinary medicine specialist and an adjunct associate professor of obstetrics and gynaecology at The University of Texas Medical Branch.
After a career in academic medicine, Dr Haver founded The Pause Life, described as a science and education-based resource for women navigating perimenopause and the menopause transition.
Through her books, unPaused podcast and digital platform, she has provided education on midlife health.
Dr Mary Claire Haver said: “I have spent my career advocating for women to receive the science-backed, no-nonsense guidance they deserve.
“I chose to partner with Midi Health because they are the only platform with the scale and medical rigour to deliver the kind of care women deserve, regardless of their zip codes.
“Together, we are setting a new standard for proactive, preventative care that meaningfully extends both lifespan and healthspan for women.”
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