The European Commission has approved Astellas Pharma's fezolinetant, a non-hormonal treatment for managing moderate-to-severe vasomotor symptoms (VMS) like hot flashes and night sweats in menopausal women.
This approval addresses a large unmet need, as up to 97% of women aged 40 to 64 in Europe experience these symptoms.
Fezolinetant, to be marketed as Veoza, offers an alternative to hormone replacement therapy, which isn't suitable for all cases.
Fezolinetant works by restoring the balance disrupted during menopause between oestrogen and neurokinin B, a brain chemical involved in regulating body temperature. By blocking neurokinin B, Veoza effectively reduces both the frequency and intensity of VMS.
The drug's approval follows promising results from the BRIGHT SKY program and the phase IIIb DAYLIGHT trial.
In these studies, fezolinetant significantly reduced VMS frequency and severity compared to a placebo. Additionally, it showed notable benefits in reducing sleep disturbances, making it a valuable option for menopausal women unsuitable for hormone therapy.