Astellas secures EC approval for VMS treatment, fezolinetant

The European Commission has approved Astellas Pharma’s Veoza^TM (fezolinetant) for treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

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.

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 Europe range from 56 percent up to 97 percent, according to some research.

“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. Rossella Nappi from the University of Pavia.

EC approved the marketing authorisation for Veoza (fezolinetant) 45mg once daily, for treatment of moderate to severe vasomotor symptoms associated with menopause.   

Trials supporting approval of Veoza for VMS

The Commission’s approval of Veoza follows a positive opinion issued in October by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

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 Europe, the United States and Canada. Findings from the most recent study, SKYLIGHT 4, were presented at The North American Menopause Society Annual Meeting in October 2022. 

The marketing authorisation for Veoza (fezolinetant) is applicable in EU Member States, as well as Iceland, Norway and Liechtenstein. Separately, fezolinetant has been approved in Switzerland. 

Fezolinetant, marketed as Veozah, received US Food and Drug Administration approval in May 2023. 

“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 European Union,” said Marci English, Vice President, Head of BioPharma Development at Astellas.