FDA accepts New Drug Application for elinzanetant

BERLIN, Germany I October 09, 2024 I Bayer has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for elinzanetant, an investigational compound aimed at treating moderate-to-severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause.

Christine Roth, Executive Vice President of Global Product Strategy and Commercialization and a member of the Pharmaceutical Leadership Team at Bayer, emphasized the importance of this development. She highlighted that the acceptance of the NDA by the FDA is a significant achievement in their mission to enhance menopause care for women in the U.S. Roth expressed optimism that, if approved, elinzanetant would provide a new non-hormonal treatment option for women experiencing moderate to severe VMS.

The NDA submission is backed by positive outcomes from the OASIS Phase III studies, specifically OASIS 1, 2, and 3, which evaluated both the efficacy and safety of elinzanetant compared to a placebo. Results from OASIS 1 and 2 were published in JAMA in August 2024, while detailed findings from OASIS 3, offering additional long-term safety data, were presented at The Menopause Society's annual meeting in September 2024.

Bayer is also working on obtaining marketing authorizations for elinzanetant from other health authorities globally.

The elinzanetant clinical development program, known as OASIS, includes four Phase III studies: OASIS 1, 2, 3, and 4. OASIS 1 and 2 focused on the efficacy and safety of daily oral doses of elinzanetant in women with moderate to severe VMS over a span of 26 weeks, involving 396 and 400 postmenopausal women aged 40 to 65 years across 184 sites in 15 countries. Patients in the elinzanetant group received a daily dose of 120 mg for 26 weeks, while the control group received a placebo for the first 12 weeks, followed by the 120 mg elinzanetant dose for the remaining 14 weeks.

OASIS 3, on the other hand, investigated the treatment of VMS over 52 weeks, involving 628 postmenopausal women aged 40 to 65 years across 83 sites in 9 countries. OASIS 4 expands the Phase III program by exploring the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for breast cancer treatment or prevention.

In addition to the OASIS program, Bayer is conducting NIRVANA, an exploratory Phase II study aimed at examining the efficacy of elinzanetant on sleep disturbances associated with menopause. This study uses polysomnography (PSG) to analyze sleep patterns and further evaluates patient-reported outcomes and the overall safety of elinzanetant.

Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in late-stage development for non-hormonal treatment of moderate to severe VMS. Administered orally once daily, it targets estrogen-sensitive neurons in the hypothalamus (KNDy neurons), which become hyperactive due to estrogen decline, leading to VMS. Elinzanetant also shows potential in reducing sleep disturbances associated with menopause.

Vasomotor symptoms, or hot flashes, result from the overactivation of the thermoregulatory pathway due to estrogen decline, which can occur naturally during menopause or be induced by medical interventions. These symptoms affect up to 80% of women during menopause, with over one-third experiencing severe symptoms that can last over a decade, significantly impacting quality of life.

The global population of women experiencing menopause is expected to reach 1.2 billion by 2030, with 47 million women entering this phase annually. Menopause, typically occurring in women’s 40s or early 50s, can also result from medical treatments such as breast cancer therapy. The decline in hormone levels during menopause leads to various symptoms, including VMS, sleep disturbances, and mood changes, which can substantially affect women’s health, quality of life, and work productivity.

Bayer, a global leader in women’s healthcare, remains committed to advancing treatments and broadening options for women worldwide. Through innovative solutions and sustainable initiatives, Bayer aims to address the unmet medical needs of women, particularly those related to menopause and reproductive health.