Bayer has submitted a marketing authorisation application to the European Medicines Agency (EMA) for its menopause treatment elinzanetant.
Bayer’s pill is indicated for the treatment of moderate to severe vasomotor symptoms – also known as hot flashes – associated with menopause. Individuals who have hot flashes from taking adjuvant endocrine therapy are also included in elinzanetant’s span, as per a 15 October press release.
The submission to the EMA comes a week after the US Food and Drug Administration (FDA) accepted a new drug application (NDA) from the German drugmaker for elinzanetant in the same indication, minus endocrine therapy inclusion. Bayer has also submitted to regulatory agencies in Australia, Canada, Switzerland, and the UK.
Hot flashes, also called hot flushes, result from decreased levels of oestrogen affecting neurons in the hypothalamus. These cells, KNDy neurons, hyperactivate the thermoregulatory pathway, causing a sudden feeling of intense warmth in the body. Up to 80% of women undergoing menopausal transition experience vasomotor symptoms, with a third of women reporting severe symptoms.
Currently, the standard approach to combat hot flashes is by taking oestrogen, but long-term hormone therapy carries risks. Elinzanetant works by non-hormonal action, modulating the KNDy neurons in the hypothalamus by dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist activity. The therapy was added to Bayer’s portfolio as part of the acquisition of UK-based KaNDy Therapeutics in 2020.
Elinzanetant has demonstrated efficacy and long-term safety in treating moderate to severe vasomotor symptoms in the four-study Phase III OASIS programme. Taking elinzanetant once-daily for 12 weeks significantly reduced the frequency of hot flashes, with reductions in sleep disturbances and menopause-related quality of life also seen.
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Data from OASIS 1 and 2 (NCT05042362 and NCT05099159) were published in the Journal of the American Medical Association (JAMA) in August 2024, with OASIS 3 (NCT05030584) providing additional efficacy and safety data over 52 weeks. Between them, the three studies enrolled over 1,400 postmenopausal women between 40 and 65 years of age. The OASIS 4 study is an ongoing expansion of the Phase III programme evaluating elinzanetant in women experiencing hot flashes due to endocrine therapy for the treatment or prevention of breast cancer.
Bayer executive vice president of global product strategy and commercialisation said: “Menopausal symptoms can differ significantly from one woman to another in both their nature and intensity. With this submission, Bayer is seeking to expand treatment choices so that clinicians can offer more personalized care that addresses the unique needs of each woman.”
If approved, elinzanetant will compete with Astellas’ Veozah (fezolinetant), an NK-3 receptor agonist, which was approved in Europe in December 2023. The therapy, which is also FDA-approved, has not been as profitable as Astellas envisaged, with demand lower than expected, as per the company’s FY2023 financial results.
Analysis by GlobalData forecasts big markets for Veozah and elinzanetant, however, with 2023 revenue predicted to reach $1.6bn and $1.2bn in 2030 for the two treatments respectively.
GlobalData is the parent company of Pharmaceutical Technology.
