Bayer's New Drug Elinzanetant Faces FDA Scrutiny: Safety Concerns Draw Attention, Menopausal Women Should Choose Cautiously!

On October 9, Bayer officially announced that its New Drug Marketing Application (NDA) has been accepted by the US Food and Drug Administration (FDA). The application is for Elinzanetant (Elinetant), a dual NK-1/NK-3 receptor antagonist, indicated for moderate to severe vasomotor symptoms (VMS) associated with menopause, commonly known as menopausal hot flashes.

The application is based on the positive results of three Phase III clinical studies, OASIS 1, OASIS 2, and OASIS 3. These studies were designed to comprehensively evaluate the efficacy and safety of Elinzanetant in the treatment of menopausal associated VMS. The results of the study showed that Elinzanetant (120mg orally once daily) was excellent in reducing the frequency and severity of moderate-to severe VMS and demonstrated a good safety profile. In the Elinzanetant treatment group, headache and fatigue were the most common adverse events.

In addition, the OASIS 1 and OASIS 2 studies observed sustained improvements across three key secondary endpoints, including a significant reduction in VMS frequency at week 1, improvements in sleep disturbances, and improvements in menopause-related quality of life.

Elinzanetant is an innovative dual NK-1 and NK-3 receptor antagonist whose unique mechanism of action lies in the regulation of a group of estrogen-sensitive neurons within the hypothalamus in the brain (KNDy neurons). During menopause, KNDy neurons become hypertrophic due to decreased estrogen levels and lead to overactivation of the thermoregulatory pathway, which in turn disrupts the body temperature control mechanism and triggers VMS. Hot flashes, one of the most common symptoms of menopause, have a significant negative impact on women's quality of life. It is predicted that by 2030, 1.2 billion women worldwide will be affected by menopausal hot flashes.

In addition to the OASIS project, Bayer is actively advancing the NIRVANA (NCT06112756) study, which aims to further evaluate Elinzanetant in the treatment of menopausal related sleep disorders.