GERMANY – Bayer has officially submitted a marketing authorization application to the European Medicines Agency (EMA) for its novel menopause treatment, elinzanetant.
The drug is designed to address moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, which significantly impact the quality of life for millions of women undergoing menopause.
Additionally, the drug may benefit individuals experiencing hot flashes as a side effect of adjuvant endocrine therapy, as Bayer highlighted in its press release on October 15.
Menopause and its impact
The global population of women experiencing menopause is projected to reach 1.2 billion by 2030, with approximately 47 million women entering this life stage annually.
Menopause is a natural transition in a woman’s life, typically occurring in the late 40s or early 50s, marked by the gradual decline in ovarian function.
This hormonal shift can lead to a variety of symptoms, including VMS, sleep disturbances, and mood changes, all of which can disrupt daily life and work productivity.
These symptoms are not only a healthcare issue but also have significant socio-economic implications.
According to Bayer, addressing these symptoms is essential to improving the quality of life and maintaining functional abilities in women experiencing menopause.
The introduction of elinzanetant offers a new therapeutic option that could enhance the well-being of millions of women worldwide.
A safer alternative to hormone therapy
Hot flashes, or vasomotor symptoms, are one of the most common and disruptive symptoms of menopause, affecting up to 80% of women during the menopausal transition.
These symptoms result from a decrease in estrogen levels, which disrupts the regulation of body temperature by KNDy neurons in the hypothalamus.
This disruption causes sudden waves of intense warmth and discomfort, often accompanied by sweating and rapid heartbeats.
While hormone replacement therapy (HRT) has been a standard treatment for hot flashes, long-term use of estrogen carries potential risks, including cardiovascular issues and an increased risk of certain cancers.
Elinzanetant offers a non-hormonal alternative by targeting the KNDy neurons through dual neurokinin-1 and 3 (NK-1 and NK-3) receptor antagonist activity, effectively modulating the thermoregulatory pathway in the brain.
Bayer added elinzanetant to its portfolio following its acquisition of UK-based KaNDy Therapeutics in 2020.
The drug’s mechanism of action provides a safer option for women who either cannot or prefer not to use hormone-based treatments for menopause-related symptoms.
Proven efficacy and safety in clinical trials
The EMA submission comes on the heels of the U.S. Food and Drug Administration (FDA) accepting Bayer’s New Drug Application (NDA) for elinzanetant.
This application covers the same indication for vasomotor symptoms but excludes the use of the drug in patients undergoing endocrine therapy.
Bayer has also filed for approval with regulatory agencies in Australia, Canada, Switzerland, and the United Kingdom.
Elinzanetant has demonstrated promising results in the four-study Phase III OASIS clinical program.
Over the course of 12 weeks, women taking the once-daily pill experienced significant reductions in the frequency and severity of hot flashes.
Additionally, the trials reported improvements in sleep disturbances and overall menopause-related quality of life.
“Elinzanetant has shown not only to be effective in reducing hot flashes but also in improving the sleep and daily functioning of women undergoing menopause,” Bayer stated.
This non-hormonal treatment could be a game-changer for women seeking relief from the often-debilitating symptoms of menopause without the risks associated with long-term hormone therapy.
