VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause.1,2 Worldwide, more than half of women 40 to 64 years of age experience VMS, with rates in
Prof.
'I've been awaiting the marketing authorization of fezolinetant. I'm happy to see this advancement in women's health and that my patients will soon have this new nonhormonal treatment option available to better control their moderate to severe VMS.'
'Fezolinetant's novel mechanism of action targets the root cause of moderate to severe VMS associated with menopause. We are proud to have developed an innovative treatment option for a condition that has lacked scientific advancement for too long and look forward to making fezolinetant available in countries across the
Before menopause, there is a balance between estrogens, a female sex hormone, and a protein made by the brain known as neurokinin B (NKB) that regulates the brain's temperature control center. As the body goes through menopause, estrogen levels decline and this balance is disrupted, which can lead to VMS. By blocking NKB binding in the temperature control center, fezolinetant reduces the number and intensity of hot flashes and night sweats.
This approval follows a positive opinion issued in October by the Committee for Medicinal Products for Human Use (CHMP) of the
Astellas has already reflected the impact from this matter in its financial forecast of the current fiscal year ending
About the BRIGHT SKY Phase 3 Program
The BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155) and SKYLIGHT 2 (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the
About VEOZA (fezolinetant)
VEOZA (fezolinetant) is a nonhormonal neurokinin 3 (NK3) receptor antagonist indicated in the EU and European Economic Area countries for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS are also known as hot flashes or night sweats. VEOZA works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to modulate neuronal activity in the brain's temperature control center (the hypothalamus) to reduce the number and intensity of hot flashes and night sweats.
About Astellas
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Email: anna.criddle@astellas.com
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