Tokyo-based Astellas Pharma has won FDA approval for Veozah (fezolinetant) 45 mg to treat moderate to severe vasomotor symptoms associated with menopause. The non-hormonal menopause treatment represents the first neurokinin 3 receptor antagonist to win FDA backing for vasomotor symptoms, which afflict 60-80% of women during menopause.
The approval was based on the BRIGHT SKY program, which included three phase 3 trials enrolling more than 3,000 women. The studies demonstrated Veozah reduced hot flash frequency and severity.
Fezolinetant is a neurokinin 3 (NK3) receptor antagonist. It works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center of the brain—the hypothalamus—to curb the frequency and severity of moderate to severe VMS.
In a statement, Astellas noted that marketing applications are under review in the European Union, Switzerland and Australia…