Astellas Pharma’s Veozah (fezolinetant) has been approved in the US to treat moderate-to-severe vasomotor symptoms (VMS) in menopausal patients.
The US Food and Drug Administration’s (FDA) decision makes the drug the first non-hormonal neurokinin 3 receptor antagonist approved for this indication.
VMS, such as hot flashes and night sweats, affect up to 80% of individuals in the US during or after the menopausal transition.
Hormone replacement therapy can be used to successfully treat symptoms, but is not recommended in all cases, so there is a demand for non-hormonal alternatives.
Before menopause, there is a balance between oestrogen and the brain chemical neurokinin B. This regulates the body’s temperature control centre located in a specific area of the brain. However, as the body goes through menopause, oestrogen levels decline and this balance is disrupted.
Astellas says Veozah addresses the root cause of VMS by blocking neurokinin B in the temperature control centre to restore the balance and reduce the number and intensity of hot flashes.
The FDA’s decision was supported by positive results from the BRIGHT SKY programme, in which Veozah was associated with a significant reduction in the frequency and severity of VMS compared to placebo.
One phase 3 study involved in the programme, SKYLIGHT 1, met its four co-primary efficacy endpoints, with Veozah significantly improving 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.
Improvements were also observed in sleep disturbance, a key secondary endpoint of the study, and the company reported that additional sleep analyses showed a higher proportion of patients in the both Veozah dose groups reported improvements at four and 12 weeks compared with placebo.
Genevieve Neal-Perry, chair, UNC School of Medicine, Department of Obstetrics and Gynaecology, said: “Today’s approval of [Veozah] is a significant and, I believe, long awaited milestone for individuals in the US who experience moderate-to-severe VMS during the menopausal transition.
“This therapy is based on our understanding of the biology behind hot flashes. I’m excited to know that patients will have the option to choose this non-hormonal treatment.”
Astellas outlined that marketing authorisation applications for Veozah are also under regulatory review in the EU, Switzerland and Australia.