GERMANY—Bayer, the German pharmaceutical giant, has recently submitted a marketing authorisation application to the European Medicines Agency (EMA) for elinzanetant, a new treatment for menopause-related symptoms.

This drug is designed to address moderate to severe vasomotor symptoms, commonly known as hot flashes, that are associated with menopause.

According to a press release dated October 15, the application also encompasses individuals who experience hot flashes as a result of taking adjuvant endocrine therapy.

This submission to the EMA comes shortly after the new drug application (NDA) for the same indication was accepted by the U.S. Food and Drug Administration (FDA).

However, it particularly excludes patients undergoing endocrine therapy.

Bayer is not limiting its efforts to Europe and the United States; the company has also filed applications with regulatory agencies in Australia, Canada, Switzerland, and the United Kingdom, indicating a robust strategy to secure approval for elinzanetant on multiple fronts.

Hot flashes occur due to decreased levels of estrogen, which impacts neurons in the hypothalamus.

This hormonal shift leads to the hyperactivation of KNDy neurons, resulting in a sudden sensation of intense warmth throughout the body.

Research shows that up to 80% of women experiencing the menopausal transition encounter vasomotor symptoms, with one-third of these women reporting severe manifestations.

Traditionally, the standard treatment for hot flashes has involved hormone replacement therapy, specifically estrogen.

However, long-term use of hormonal treatments carries various health risks, prompting a need for alternative therapies.

Elinzanetant offers a non-hormonal approach by targeting the KNDy neurons in the hypothalamus through dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist activity.

This innovative therapy was incorporated into Bayer’s portfolio following its 2020 acquisition of KaNDy Therapeutics in the UK.

The drug has shown promising results in the Phase III OASIS clinical program, which comprises four studies evaluating its efficacy and long-term safety for treating moderate to severe vasomotor symptoms.

Participants who took elinzanetant daily for 12 weeks reported a significant reduction in the frequency of hot flashes, alongside improvements in sleep disturbances and overall quality of life related to menopause.

Findings from the OASIS 1 and 2 studies (NCT05042362 and NCT05099159) were published in the Journal of the American Medical Association (JAMA) in August 2024.

 Additionally, the OASIS 3 study (NCT05030584) provided further insights into the drug’s efficacy and safety over a 52-week period.

These three studies involved more than 1,400 postmenopausal women aged between 40 and 65 years.

An ongoing study, OASIS 4, is exploring elinzanetant’s effectiveness in women experiencing hot flashes due to endocrine therapy as part of breast cancer treatment or prevention.

Commenting on this development, Christine Roth, Executive Vice President of Global Product Strategy and Commercialization at Bayer, emphasized the varied nature and intensity of women’s menopausal symptoms.

She noted that Bayer’s goal with this submission is to broaden treatment options, enabling healthcare providers to deliver more personalized care that meets each woman’s individual needs.

If approved, elinzanetant will compete with Astellas’ Veozah (fezolinetant), an NK-3 receptor agonist that received European approval in December 2023.

Although Veozah has also gained FDA approval, it has not performed as well commercially as Astellas had anticipated, with demand falling short of projections, according to the company’s FY2023 financial results.

Nevertheless, market analyses by GlobalData predict significant revenue potential for both Veozah and elinzanetant, with forecasts estimating revenues of US$1.6 billion and US$1.2 billion, respectively, by 2030.

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