Results for Astellas’ non-hormonal menopause drug published in The Lancet

Astellas Pharma’s investigational non-hormonal compound, fezolinetant, has been associated with significant improvements in moderate to severe vasomotor symptoms (VMS) due to menopause, according to detailed phase 3 results recently published in The Lancet.

VMS, such as hot flashes and night sweats, are the most common symptoms of menopause and can substantially impact daily quality of life.

Hormone replacement therapy can be used to successfully treat symptoms, but can slightly increase the risk of certain health conditions, so there is a demand for non-hormonal alternatives.

Astellas’ phase 3 SKYLIGHT 1 study met its four co-primary efficacy endpoints, with fezolinetant significantly reducing the frequency and severity of VMS episodes after four and 12 weeks of treatment compared to placebo.

These improvements were observed as early as week one, the company said, and the effects were maintained throughout the remainder of the 52-week study period.

Commenting on the significance of the results, Genevieve Neal-Perry, chair, UNC School of Medicine Department of Obstetrics and Gynaecology, said: “The SKYLIGHT 1 study showed that women receiving fezolinetant experienced a reduction in the frequency and severity of VMS and improvements in quality of life over the one-year treatment period.

“As a healthcare provider, I truly understand the burden of VMS due to menopause on my own patients, and I’m really excited about this potential new non-hormonal treatment option to help women experiencing moderate to severe VMS.”

Improvements were also observed in sleep disturbance, a key secondary endpoint of the study, but statistical significance was not met for fezolinetant dose at 12 weeks.

The company also reported that additional sleep analyses showed a higher proportion of patients in the both fezolinetant dose groups reported improvements at four and 12 weeks compared with placebo.

Ahsan Arozullah, senior vice president and head of development therapeutic areas at Astellas, said: “This publication of the SKYLIGHT 1 study is another important report of a phase 3 randomised trial assessing the utility of an investigational non-hormonal agent, fezolinetant, that targets the neurokinin 3 receptor to reduce the frequency and severity of moderate to severe VMS due to menopause.”

Further evidence of the efficacy of fezolinetant was shown in the analyses of the quality of life questionnaire given to patients in the study, which showed a significant and clinically meaningful improvement at four and 12 weeks that was maintained through 52 weeks.