HQ Team
March 19, 2024: Bayer AG, a German pharmaceutical major, will seek regulatory approval for its menopausal drug after the final trials proved to reduce hot flashes.
The third-stage trial evaluating the efficacy and long-term safety of the investigational compound elinzanetant “successfully met the primary endpoint, demonstrating a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms or hot flashes,” according to a company statement.
The long-term safety profile observed over 52 weeks in the final study is “overall consistent” with earlier trials.
The late-stage trial addressed the long-term profile of elinzanetant, an oral drug administered once daily.
Ovarian function decline
The investigational drug had “consistently” shown positive data for the treatment of moderate to severe vasomotor symptoms associated with menopause, said Dr Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division.
“We are looking forward to sharing the full data at upcoming medical conferences as we move towards submitting to health authorities,” he said.
Nick Panay, Principal Investigator of the study said: “We must continue to broaden therapeutic options that will effectively meet the significant needs of menopausal women.”
Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function, and it usually occurs in women during their 40s or early 50s.
Quality of life
It can also be the result of surgical or medical treatment, such as breast cancer treatment.
The hormonal decline can lead to various symptoms that can substantially affect a woman’s health, quality of life, healthcare utilisation and work productivity.
Bayer’s late-stage trial was conducted on 628 postmenopausal women between 40 and 65 years old across 83 sites in nine countries.
Hot flashes are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes of seeking medical attention during this phase of a woman’s life.
Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with a relevant impact on quality of life.
47 million women a year
Vasomotor symptoms may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence.
For these women, there are currently no approved treatment options.
By 2030, the world population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million new women entering this phase each year.
The most frequently reported and disruptive symptoms during the menopausal transition are sleep disturbances and mood changes.
In fiscal 2023, the Bayer group had sales of 47.6 billion euros.
