The
Fezolinetant is a nonhormonal neurokinin 3 (NK3) receptor antagonist. It works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to modulate neuronal activity in the hypothalamus, reducing the number and intensity of hot flashes and night sweats.
Rates of VMS in
These symptoms, also known as VMS, can have a disruptive impact on women’s daily activities and overall quality of life. Rates of VMS in
"I’m happy to see…that my patients will soon have this new nonhormonal treatment option available to better control their moderate to severe VMS,” commented Prof.
EC approved the marketing authorisation for Veozatm (fezolinetant) 45mg once daily, for treatment of moderate to severe vasomotor symptoms associated with menopause.
Trials supporting approval of Veozatm for VMS
The Commission's approval of Veozatm follows a positive opinion issued in October by the
This opinion was based on the results from the BRIGHT SKY programme, which included three Phase III clinical trials to monitor efficacy and safety in women with moderate to severe VMS. These studies (SKYLIGHT 1, SKYLIGHT 2 and SKYLIGHT 4) enrolled some 3,000 patients across
The marketing authorisation for Veozatm (fezolinetant) is applicable in EU Member States, as well as
Fezolinetant, marketed as Veozah, received
"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
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