Vezoah is approved by the FDA for treatment of vasomotor symptoms due to menopause

Vezoah is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause.

VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause. VMS are the most common symptoms of menopause for which women seek treatment. In the U.S., about 60% to 80% of women experience these symptoms during or after the menopausal transition. VMS can have a disruptive impact on women's daily activities and overall quality of life.

The approval is supported by results from the BRIGHT SKY program, which included three Phase III clinical trials as part of a development program that collectively enrolled over 3,000 individuals across the U.S., Canada and Europe. Results from the SKYLIGHT 1 and SKYLIGHT 2 pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS due to menopause. Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant.