Bayer Submits NDA to U.S. FDA for Elinzanetant for Treating Menopausal Vasomotor Symptoms

In a significant development, Bayer has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for elinzanetant, intended to treat moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause. This application is grounded on the positive outcomes of the Phase III OASIS 1, 2, and 3 clinical studies.

Christine Roth, Executive Vice President at Bayer, emphasized the far-reaching impact of menopausal symptoms on women's health and quality of life, noting that 27 million women in the U.S. are currently experiencing menopause. Roth highlighted the absence of adequate treatment options due to gaps in awareness and education. The FDA submission of elinzanetant is a pivotal step towards providing a new non-hormonal treatment option, reinforcing Bayer's commitment to women's health globally.

The OASIS 1, 2, and 3 studies focused on the efficacy and safety of elinzanetant, administered at a dosage of 120 mg orally once daily. These trials showed significant reductions in the frequency and severity of moderate-to-severe VMS, along with a favorable safety profile. Common side effects were headache and fatigue. The studies also demonstrated improvements in secondary endpoints, such as reduction in VMS frequency within the first week, better sleep, and enhanced menopause-related quality of life.

OASIS 1 and 2 results were recently presented at the 2024 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting. The OASIS 3 study, which provided additional efficacy and safety data over 52 weeks, had its topline results announced in March 2024, with further details to be shared in an upcoming scientific gathering.

Hot flashes are among the most commonly reported symptoms during menopause, affecting women's quality of life and often leading them to seek medical advice. By 2030, menopause is expected to impact 1.2 billion women globally. The availability of additional treatment options is essential to give women choices in managing these symptoms.

Bayer plans to submit applications for elinzanetant to other health authorities worldwide. The OASIS 1 and 2 studies are double-blind, randomized, placebo-controlled, and multicenter trials conducted over 26 weeks, involving nearly 800 postmenopausal women across 15 countries. The OASIS 3 study, similar in design but extending to 52 weeks, included 628 postmenopausal women across nine countries.

The Phase III OASIS clinical program for elinzanetant encompasses four studies, with OASIS 4 focusing on women experiencing VMS due to endocrine therapy for breast cancer. These studies are built on positive findings from earlier Phase II studies, RELENT-1 and SWITCH-1, which validated elinzanetant's safety and efficacy.

Bayer is also conducting the NIRVANA study, an exploratory Phase II trial aimed at assessing elinzanetant's effects on sleep disturbances linked to menopause. This trial employs polysomnography, a validated method for studying sleep and its disturbances, along with patient-reported outcomes and safety evaluations.

Elinzanetant is a dual neurokinin-1 and 3 receptor antagonist being developed as a non-hormonal treatment for VMS. It targets estrogen-sensitive neurons in the brain's hypothalamus to modulate body heat control mechanisms, potentially reducing VMS and associated sleep disturbances.

Vasomotor symptoms, resulting from decreased estrogen levels, affect up to 80% of women during menopause, with severe symptoms impacting over a third and potentially lasting a decade or more.

Menopause, typically occurring in women in their 40s or early 50s, can also result from medical treatments like breast cancer therapy. It leads to various symptoms, significantly affecting health, quality of life, healthcare utilization, and work productivity. Addressing these symptoms is crucial for maintaining functional ability and quality of life.

Bayer, a global leader in women's healthcare, is committed to innovative treatments for conditions like menopause, birth control, and gynecological diseases. The company aims to provide family planning access to 100 million women annually in low-and-middle-income countries by 2030, aligning with the United Nations' Sustainable Development Goals.

Bayer, a leader in healthcare and nutrition, continues to advance sustainable development and innovation, employing around 100,000 people globally with a significant focus on research and development.

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