Menopause drug moves a step closer to patient usage

A treatment for hot flashes developed by global pharma firm Bayer has had its new drug application accepted by the US Food and Drug Administration (FDA).

The investigational compound elinzanetant is designed for the treatment of moderate-to-severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause.

The new drug application (NDA) acceptance means it will now be reviewed by the agency and, if successful, “elinzanetant will offer a new non-hormonal option to women”, says Bayer.

Christine Roth, executive vice president at Bayer, says:“The NDA acceptance of elinzanetant by the FDA marks a significant milestone in our efforts to advance menopause care for women in the US.”

The NDA application is based on the positive results from phase III studies evaluating the efficacy and safety of elinzanetant versus placebo.

The results, supporting efficacy and long-term safety, were presented at The Menopause Society’s (TMS) annual meeting last month.

Bayer is continuing to submit applications for authorisations from other health authorities too.

Hot flashes result from hyper-activation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.

VMS are reported by up to 80 per cent of women at some point during the menopausal transition and are one of the leading causes for 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 relevant impact on quality of life.

VMS 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.

Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS.

It may also decrease sleep disturbances associated with menopause.